FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
1
Product Code
BXM
Stimulator, Nerve, Ac-Powered
2
Product Code
BXN
Stimulator, Nerve, Battery-Powered
2
Product Code
BXO
Transducer, Gas Pressure
1
Product Code
BXP
Transducer, Gas Flow
1
Product Code
BXX
Calibrator, Pressure, Gas
1
Product Code
BXY
Flowmeter, Calibration, Gas
1
Product Code
BYM
Tube, Thorpe, Uncompensated
1
Product Code
BYR
Transducer, Gas Pressure, Differential
1
Product Code
BZQ
Monitor, Breathing Frequency
2
Product Code
K
22
3681
Respiree Cardio-Respiratory Monitor
2
Cleared 510(K)
K
22
1555
Dozee VS
2
Cleared 510(K)
K
22
3246
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
2
Cleared 510(K)
K
22
0111
RespiraSense
2
Cleared 510(K)
K
21
1387
Breathe Easy Mobile Respiratory Monitor (MRM)
2
Cleared 510(K)
K
20
2018
Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
2
Cleared 510(K)
K
20
0445
The C100 Contactless Breathing Monitor
2
Cleared 510(K)
K
19
0734
Linshom Respiratory Monitoring Device (LRMD)
2
Cleared 510(K)
K
19
0775
The RHEA Vital Sign Vigilance System
2
Cleared 510(K)
K
17
3976
Masimo Acoustic Respiration Sensors, infant and neonate
2
Cleared 510(K)
K
18
0079
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
2
Cleared 510(K)
K
17
1836
EarlySense Bed Sensing Unit
2
Cleared 510(K)
K
15
2911
EarlySense Insight Sytem
2
Cleared 510(K)
K
15
1940
Thora-3Di, Model T-01
2
Cleared 510(K)
K
13
3661
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
2
Cleared 510(K)
K
13
2320
INTELLIVUE CL RESPIRATION POD
2
Cleared 510(K)
K
13
0570
NEUROVISION MEDICAL MOTION SENSOR
2
Cleared 510(K)
K
13
1379
EARLYSENSE
2
Cleared 510(K)
K
12
2223
NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
2
Cleared 510(K)
K
12
0465
EARLYSENSE (EVERON) SYSTEM
2
Cleared 510(K)
K
11
1933
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
2
Cleared 510(K)
K
10
3631
SLEEPMINDER BREATHING FREQUENCY INDICATOR
2
Cleared 510(K)
K
10
0773
KAI SPOT MODEL KMS 200
2
Cleared 510(K)
K
09
2062
EVERON 1.0
2
Cleared 510(K)
K
09
2685
PNEUMOTHERML, MODEL: 5800
2
Cleared 510(K)
K
09
0273
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
2
Cleared 510(K)
K
08
2465
EVERON
2
Cleared 510(K)
K
08
0922
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
2
Cleared 510(K)
K
07
0375
EARLYSENSE ES-16 SYSTEM
2
Cleared 510(K)
K
06
2883
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
2
Cleared 510(K)
K
05
1779
ANDROFLOW - RESPIRATORY RATE MONITOR
2
Cleared 510(K)
K
04
0605
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
2
Cleared 510(K)
K
00
3704
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
2
Cleared 510(K)
K
00
1743
ULTIMA SMARTBELT, MODEL 0560
2
Cleared 510(K)
K
00
1030
RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
2
Cleared 510(K)
K
99
1411
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
2
Cleared 510(K)
K
98
3449
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
2
Cleared 510(K)
K
98
1725
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
2
Cleared 510(K)
K
98
4431
ULTIMA AIRFLOW PRESSURE SENSOR
2
Cleared 510(K)
K
98
2550
BROWSER (EVENT SOFTWARE) MODEL # 4500E
2
Cleared 510(K)
K
98
1445
ULTIMA AIRFLOW SENSOR, 0510
2
Cleared 510(K)
K
98
2216
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
2
Cleared 510(K)
K
98
1728
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
2
Cleared 510(K)
K
96
1972
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
2
Cleared 510(K)
K
96
2781
COROMETRICS MODEL 510 AND 511 MONITOR
2
Cleared 510(K)
K
96
0851
THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
2
Cleared 510(K)
K
95
3363
OXIFLOW DIGITAL RECORDER
2
Cleared 510(K)
K
94
3308
MODEL 510 INFANT MONITOR
2
Cleared 510(K)
K
94
2170
MODEL 511 INFANT MONITOR
2
Cleared 510(K)
K
94
1759
SNORING SENSOR
2
Cleared 510(K)
K
94
0014
PLM SENSOR, MODEL PLM1
2
Cleared 510(K)
K
92
4875
MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
2
Cleared 510(K)
K
93
5518
MOVING IMAGES(TM)
2
Cleared 510(K)
K
93
2902
MAGNUM
2
Cleared 510(K)
K
93
0790
ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
2
Cleared 510(K)
K
92
3737
MODEL MEDILOG RAPIDE
2
Cleared 510(K)
K
92
1819
EDENTEC MODEL 3710 I DIGITAL PRINTER
2
Cleared 510(K)
K
92
5364
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
2
Cleared 510(K)
K
92
3402
CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
2
Cleared 510(K)
K
92
2112
EASYFLOW
2
Cleared 510(K)
K
91
3749
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
2
Cleared 510(K)
K
91
1874
SLEEPTRACE 2000
2
Cleared 510(K)
K
91
1386
SLEEPMASTER
2
Cleared 510(K)
K
91
2415
MEDICAL SAFETY CABLE AND LEAD SYSTEM
2
Cleared 510(K)
K
90
4432
SLEEP I/T-5 AND SLEEP I/T-8
2
Cleared 510(K)
K
90
5575
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
2
Cleared 510(K)
K
90
5520
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
2
Cleared 510(K)
K
90
3020
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
2
Cleared 510(K)
K
90
3011
RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
2
Cleared 510(K)
K
90
4396
SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM
2
Cleared 510(K)
K
90
3300
RESP-EZ(TM) RESPIRATORY MONITORING BELT
2
Cleared 510(K)
K
90
3287
MODEL 900S APNEA/HEART MONITOR
2
Cleared 510(K)
K
90
0264
R-BAND(TM) RESPIRATORY SENSOR
2
Cleared 510(K)
K
88
4120
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
2
Cleared 510(K)
K
90
2785
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
2
Cleared 510(K)
K
90
1656
MODEL 9200 RESPIRATION/HEART RATE MONITOR
2
Cleared 510(K)
K
89
6934
KNIGHTWATCH SYSTEM
2
Cleared 510(K)
K
90
0730
ARVEE APNEA MONITOR, MODEL 4800
2
Cleared 510(K)
K
90
1466
MESAMIV RECORDER
2
Cleared 510(K)
K
90
0826
'APNEA-ELECTRODE'
2
Cleared 510(K)
K
89
4641
MESAM RECORDER
2
Cleared 510(K)
K
89
1486
AR-800PA RESPIRATION MODULE
2
Cleared 510(K)
K
89
1676
ARVEE APNEA MONITOR, MODEL 2400
2
Cleared 510(K)
K
88
3158
RESPIRATORY AIRWAY TUBE MONITOR (RATM)
2
Cleared 510(K)
K
88
4637
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
2
Cleared 510(K)
K
88
2377
HEALTH-WATCH BED MONITOR
2
Cleared 510(K)
K
88
0725
SAM(TM) MODEL ONE
2
Cleared 510(K)
K
86
2747
8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS
2
Cleared 510(K)
K
88
1266
MODEL 9216 RESPIRATION/HEART RATE MONITOR
2
Cleared 510(K)
K
87
2833
BREATHGUARD APNEA MONITOR
2
Cleared 510(K)
K
87
4898
CM 3000 THE MONITOR
2
Cleared 510(K)
K
87
4814
HEALTHDYNE RATE METER
2
Cleared 510(K)
K
87
3791
MODEL 500E INFANT MONITORING SYSTEM
2
Cleared 510(K)
K
87
1813
VITALOG PMS-8 (MODIFICATION)
2
Cleared 510(K)
K
87
2631
INFANT MONITOR, MODEL 2400
2
Cleared 510(K)
K
87
2954
MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR
2
Cleared 510(K)
K
87
1576
ROKONICS 8500
2
Cleared 510(K)
K
87
1551
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
2
Cleared 510(K)
K
87
1302
MODEL 2000W OPTION H CONFIGURATION
2
Cleared 510(K)
K
87
0835
ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)
2
Cleared 510(K)
K
86
4261
MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR
2
Cleared 510(K)
K
86
4419
LIFEWATCH(R) PORTABLE MONITORING SYSTEM
2
Cleared 510(K)
K
87
0661
LIFEWATCH PLUS
2
Cleared 510(K)
K
86
2462
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
2
Cleared 510(K)
K
86
4487
LIFEWATCH SENSOR BELT
2
Cleared 510(K)
K
85
2249
KONTRON VITALMON 5010 PATIENT MONITOR
2
Cleared 510(K)
K
86
3612
MONAGHAN RVM, MODEL 760 AND 761
2
Cleared 510(K)
K
86
2962
APNET RESPIRATION MONITOR
2
Cleared 510(K)
K
86
1326
RESPISOMNOGRAPH
2
Cleared 510(K)
K
85
4333
BIOCHEM 515 RESPIRATION MONITOR
2
Cleared 510(K)
K
86
1484
INFANT MONITOR
2
Cleared 510(K)
K
86
1423
DEMAND OXYGEN SAVER SYSTEM (D02S)
2
Cleared 510(K)
K
86
1407
NEO-TRAK 502 INFANT MONITOR
2
Cleared 510(K)
K
86
1743
AS165 RESPIRATION MONITOR
2
Cleared 510(K)
K
85
4705
INFAGUARD TM
2
Cleared 510(K)
K
85
4355
GREENLEAF SMART POLYGRAPH PROGRAM
2
Cleared 510(K)
K
86
0455
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
2
Cleared 510(K)
K
86
0254
HEALTHDYNE'S EVENT RECORDER SYSTEM
2
Cleared 510(K)
K
85
3252
EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM
2
Cleared 510(K)
K
85
1819
ROKONICS SENTRY MODEL 8500
2
Cleared 510(K)
K
85
3047
MONAGHAN RVM, MODEL 760 OR MODEL 761
2
Cleared 510(K)
K
85
1889
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
2
Cleared 510(K)
K
85
3303
LIFELINC LEADWIRE
2
Cleared 510(K)
K
85
3452
LIFE LINC PATIENT CABLE
2
Cleared 510(K)
K
85
3084
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
2
Cleared 510(K)
K
84
4327
EDENTEC MODEL 2000W APNEA MONITOR
2
Cleared 510(K)
K
85
2515
ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR
2
Cleared 510(K)
K
85
0504
COROMETRICS 500 INFANT MONITOR
2
Cleared 510(K)
K
84
1392
BIOMATT-1
2
Cleared 510(K)
K
84
3681
RESPIRATION & HEART RATE MONITOR 530
2
Cleared 510(K)
K
84
2048
SUN-ONE
2
Cleared 510(K)
K
84
3546
INFANT MONITOR 16900
2
Cleared 510(K)
K
84
0488
LIFECYCLE AEROBIC MONITOR 123
2
Cleared 510(K)
K
83
1601
APNEA ALARM FOR ADULT-PEDIATRIC & NEON
2
Cleared 510(K)
K
83
1650
ANESTHESIA/RESPIRATORY DISCONNECT -
2
Cleared 510(K)
K
82
3563
EEG & RESPIRATION MODULES POLYGRAPH
2
Cleared 510(K)
K
82
2819
TRIMED 510 APNEA MONITOR
2
Cleared 510(K)
K
82
1731
HEALTHDYNE MODEL 16900 INFANT MONITOR
2
Cleared 510(K)
K
82
0778
RESPIRATION MONITOR 1000
2
Cleared 510(K)
K
82
0645
INFANT MONITOR
2
Cleared 510(K)
K
82
0374
JLS GROUP INFANT MONITOR
2
Cleared 510(K)
K
81
3507
INFALERT
2
Cleared 510(K)
K
81
2873
MEDICON #8200 AMS
2
Cleared 510(K)
K
81
2667
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
2
Cleared 510(K)
K
81
2045
INFANT APNEA MONITOR MODEL 100
2
Cleared 510(K)
K
81
2044
RESPIRATION RATE MONITOR 120/121
2
Cleared 510(K)
K
81
1865
VMA PEDIATRIC APNEA MATTRESS
2
Cleared 510(K)
K
81
1628
OECO APNEA MONITOR
2
Cleared 510(K)
K
81
1265
RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)
2
Cleared 510(K)
K
81
1014
RESPIRATORY SENSOR
2
Cleared 510(K)
K
81
0175
NEO NATAL RESPIRATION FUNCTION BLOCK
2
Cleared 510(K)
K
81
0174
RESPIRATION FUNCTION BLOCKS
2
Cleared 510(K)
K
80
2205
ECG/RESPIRATION STIMULATOR
2
Cleared 510(K)
K
80
2046
PDS MODEL 3000 ADULT RESPIRATION MODULE
2
Cleared 510(K)
K
80
1894
RESPONDER II
2
Cleared 510(K)
K
79
2528
RESPIRATION/APNEA AMPLIFIER MODEL 3105
2
Cleared 510(K)
K
79
0304
PREAMPLIFIER MODULE, EKG RESPIRATION
2
Cleared 510(K)
K
78
2045
MONITOR HS7
2
Cleared 510(K)
K
78
2044
MONITOR HS8
2
Cleared 510(K)
K
78
1158
ALARM UNIT, BATTERY OPERATED
2
Cleared 510(K)
K
78
1515
MODEL LS-80 ADULT VENTILATION MONITOR
2
Cleared 510(K)
K
77
1407
LUNG VOLUME & PRESSURE MONITOR
2
Cleared 510(K)
K
77
1019
LUNG-MECHANICS MONITOR
2
Cleared 510(K)
K
77
0250
GOWN, SURGICAL, SURGINE
2
Cleared 510(K)
K
76
0339
MONITOR, RESPIRATORY (CPAP)
2
Cleared 510(K)
K
76
0340
RESPIRATORY SUPPORT SYSTEM, NEONATAL
2
Cleared 510(K)
CAN
Regulator, Pressure, Gas Cylinder
1
Product Code
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
2
Product Code
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
1
Product Code
CBA
Monitor, Air Embolism, Ultrasonic
2
Product Code
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
1
Product Code
ECX
Cylinder, Compressed Gas, And Valve
1
Product Code
FLS
Monitor, Apnea, Facility Use
2
Product Code
JAX
Pneumotachometer
2
Product Code
JEZ
Monitor, Lung Water Measurement
3
Product Code
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
2
Product Code
KOI
Stimulator, Nerve, Peripheral, Electric
2
Product Code
LKD
Monitor, Carbon-Dioxide, Cutaneous
2
Product Code
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
2
Product Code
MNR
Ventilatory Effort Recorder
2
Product Code
MRP
Analyzer, Nitric Oxide
2
Product Code
MRQ
Analyzer, Nitrogen Dioxide
2
Product Code
NPF
Monitor, Apnea, Home Use
2
Product Code
PRK
Device Indicating An Exhalation Event
2
Product Code
PUG
Analyzer, Nitrogen Dioxide, Exempt
2
Product Code
PXE
Pressure Monitoring (Air/Gas) Kit
1
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-c—monitoring-devices
/
BZQ
/
K923402
View Source
CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K923402
510(k) Type
Traditional
Applicant
PRO-TECH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/30/1992
Days to Decision
173 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
BXM
Stimulator, Nerve, Ac-Powered
BXN
Stimulator, Nerve, Battery-Powered
BXO
Transducer, Gas Pressure
BXP
Transducer, Gas Flow
BXX
Calibrator, Pressure, Gas
BXY
Flowmeter, Calibration, Gas
BYM
Tube, Thorpe, Uncompensated
BYR
Transducer, Gas Pressure, Differential
BZQ
Monitor, Breathing Frequency
K
22
3681
Respiree Cardio-Respiratory Monitor
K
22
1555
Dozee VS
K
22
3246
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
K
22
0111
RespiraSense
K
21
1387
Breathe Easy Mobile Respiratory Monitor (MRM)
K
20
2018
Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
K
20
0445
The C100 Contactless Breathing Monitor
K
19
0734
Linshom Respiratory Monitoring Device (LRMD)
K
19
0775
The RHEA Vital Sign Vigilance System
K
17
3976
Masimo Acoustic Respiration Sensors, infant and neonate
K
18
0079
Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
K
17
1836
EarlySense Bed Sensing Unit
K
15
2911
EarlySense Insight Sytem
K
15
1940
Thora-3Di, Model T-01
K
13
3661
CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
K
13
2320
INTELLIVUE CL RESPIRATION POD
K
13
0570
NEUROVISION MEDICAL MOTION SENSOR
K
13
1379
EARLYSENSE
K
12
2223
NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
K
12
0465
EARLYSENSE (EVERON) SYSTEM
K
11
1933
COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
K
10
3631
SLEEPMINDER BREATHING FREQUENCY INDICATOR
K
10
0773
KAI SPOT MODEL KMS 200
K
09
2062
EVERON 1.0
K
09
2685
PNEUMOTHERML, MODEL: 5800
K
09
0273
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
K
08
2465
EVERON
K
08
0922
SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
K
07
0375
EARLYSENSE ES-16 SYSTEM
K
06
2883
GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
K
05
1779
ANDROFLOW - RESPIRATORY RATE MONITOR
K
04
0605
DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
K
00
3704
OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
K
00
1743
ULTIMA SMARTBELT, MODEL 0560
K
00
1030
RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
K
99
1411
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K
98
3449
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
K
98
1725
OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
K
98
4431
ULTIMA AIRFLOW PRESSURE SENSOR
K
98
2550
BROWSER (EVENT SOFTWARE) MODEL # 4500E
K
98
1445
ULTIMA AIRFLOW SENSOR, 0510
K
98
2216
ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
K
98
1728
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
K
96
1972
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
K
96
2781
COROMETRICS MODEL 510 AND 511 MONITOR
K
96
0851
THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
K
95
3363
OXIFLOW DIGITAL RECORDER
K
94
3308
MODEL 510 INFANT MONITOR
K
94
2170
MODEL 511 INFANT MONITOR
K
94
1759
SNORING SENSOR
K
94
0014
PLM SENSOR, MODEL PLM1
K
92
4875
MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
K
93
5518
MOVING IMAGES(TM)
K
93
2902
MAGNUM
K
93
0790
ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
K
92
3737
MODEL MEDILOG RAPIDE
K
92
1819
EDENTEC MODEL 3710 I DIGITAL PRINTER
K
92
5364
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K
92
3402
CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
K
92
2112
EASYFLOW
K
91
3749
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
K
91
1874
SLEEPTRACE 2000
K
91
1386
SLEEPMASTER
K
91
2415
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K
90
4432
SLEEP I/T-5 AND SLEEP I/T-8
K
90
5575
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K
90
5520
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
K
90
3020
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
K
90
3011
RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
K
90
4396
SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM
K
90
3300
RESP-EZ(TM) RESPIRATORY MONITORING BELT
K
90
3287
MODEL 900S APNEA/HEART MONITOR
K
90
0264
R-BAND(TM) RESPIRATORY SENSOR
K
88
4120
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K
90
2785
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K
90
1656
MODEL 9200 RESPIRATION/HEART RATE MONITOR
K
89
6934
KNIGHTWATCH SYSTEM
K
90
0730
ARVEE APNEA MONITOR, MODEL 4800
K
90
1466
MESAMIV RECORDER
K
90
0826
'APNEA-ELECTRODE'
K
89
4641
MESAM RECORDER
K
89
1486
AR-800PA RESPIRATION MODULE
K
89
1676
ARVEE APNEA MONITOR, MODEL 2400
K
88
3158
RESPIRATORY AIRWAY TUBE MONITOR (RATM)
K
88
4637
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
K
88
2377
HEALTH-WATCH BED MONITOR
K
88
0725
SAM(TM) MODEL ONE
K
86
2747
8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS
K
88
1266
MODEL 9216 RESPIRATION/HEART RATE MONITOR
K
87
2833
BREATHGUARD APNEA MONITOR
K
87
4898
CM 3000 THE MONITOR
K
87
4814
HEALTHDYNE RATE METER
K
87
3791
MODEL 500E INFANT MONITORING SYSTEM
K
87
1813
VITALOG PMS-8 (MODIFICATION)
K
87
2631
INFANT MONITOR, MODEL 2400
K
87
2954
MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR
K
87
1576
ROKONICS 8500
K
87
1551
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
K
87
1302
MODEL 2000W OPTION H CONFIGURATION
K
87
0835
ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)
K
86
4261
MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR
K
86
4419
LIFEWATCH(R) PORTABLE MONITORING SYSTEM
K
87
0661
LIFEWATCH PLUS
K
86
2462
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K
86
4487
LIFEWATCH SENSOR BELT
K
85
2249
KONTRON VITALMON 5010 PATIENT MONITOR
K
86
3612
MONAGHAN RVM, MODEL 760 AND 761
K
86
2962
APNET RESPIRATION MONITOR
K
86
1326
RESPISOMNOGRAPH
K
85
4333
BIOCHEM 515 RESPIRATION MONITOR
K
86
1484
INFANT MONITOR
K
86
1423
DEMAND OXYGEN SAVER SYSTEM (D02S)
K
86
1407
NEO-TRAK 502 INFANT MONITOR
K
86
1743
AS165 RESPIRATION MONITOR
K
85
4705
INFAGUARD TM
K
85
4355
GREENLEAF SMART POLYGRAPH PROGRAM
K
86
0455
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING
K
86
0254
HEALTHDYNE'S EVENT RECORDER SYSTEM
K
85
3252
EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM
K
85
1819
ROKONICS SENTRY MODEL 8500
K
85
3047
MONAGHAN RVM, MODEL 760 OR MODEL 761
K
85
1889
CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY
K
85
3303
LIFELINC LEADWIRE
K
85
3452
LIFE LINC PATIENT CABLE
K
85
3084
MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)
K
84
4327
EDENTEC MODEL 2000W APNEA MONITOR
K
85
2515
ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR
K
85
0504
COROMETRICS 500 INFANT MONITOR
K
84
1392
BIOMATT-1
K
84
3681
RESPIRATION & HEART RATE MONITOR 530
K
84
2048
SUN-ONE
K
84
3546
INFANT MONITOR 16900
K
84
0488
LIFECYCLE AEROBIC MONITOR 123
K
83
1601
APNEA ALARM FOR ADULT-PEDIATRIC & NEON
K
83
1650
ANESTHESIA/RESPIRATORY DISCONNECT -
K
82
3563
EEG & RESPIRATION MODULES POLYGRAPH
K
82
2819
TRIMED 510 APNEA MONITOR
K
82
1731
HEALTHDYNE MODEL 16900 INFANT MONITOR
K
82
0778
RESPIRATION MONITOR 1000
K
82
0645
INFANT MONITOR
K
82
0374
JLS GROUP INFANT MONITOR
K
81
3507
INFALERT
K
81
2873
MEDICON #8200 AMS
K
81
2667
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K
81
2045
INFANT APNEA MONITOR MODEL 100
K
81
2044
RESPIRATION RATE MONITOR 120/121
K
81
1865
VMA PEDIATRIC APNEA MATTRESS
K
81
1628
OECO APNEA MONITOR
K
81
1265
RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)
K
81
1014
RESPIRATORY SENSOR
K
81
0175
NEO NATAL RESPIRATION FUNCTION BLOCK
K
81
0174
RESPIRATION FUNCTION BLOCKS
K
80
2205
ECG/RESPIRATION STIMULATOR
K
80
2046
PDS MODEL 3000 ADULT RESPIRATION MODULE
K
80
1894
RESPONDER II
K
79
2528
RESPIRATION/APNEA AMPLIFIER MODEL 3105
K
79
0304
PREAMPLIFIER MODULE, EKG RESPIRATION
K
78
2045
MONITOR HS7
K
78
2044
MONITOR HS8
K
78
1158
ALARM UNIT, BATTERY OPERATED
K
78
1515
MODEL LS-80 ADULT VENTILATION MONITOR
K
77
1407
LUNG VOLUME & PRESSURE MONITOR
K
77
1019
LUNG-MECHANICS MONITOR
K
77
0250
GOWN, SURGICAL, SURGINE
K
76
0339
MONITOR, RESPIRATORY (CPAP)
K
76
0340
RESPIRATORY SUPPORT SYSTEM, NEONATAL
CAN
Regulator, Pressure, Gas Cylinder
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
CBA
Monitor, Air Embolism, Ultrasonic
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
ECX
Cylinder, Compressed Gas, And Valve
FLS
Monitor, Apnea, Facility Use
JAX
Pneumotachometer
JEZ
Monitor, Lung Water Measurement
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
KOI
Stimulator, Nerve, Peripheral, Electric
LKD
Monitor, Carbon-Dioxide, Cutaneous
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
MNR
Ventilatory Effort Recorder
MRP
Analyzer, Nitric Oxide
MRQ
Analyzer, Nitrogen Dioxide
NPF
Monitor, Apnea, Home Use
PRK
Device Indicating An Exhalation Event
PUG
Analyzer, Nitrogen Dioxide, Exempt
PXE
Pressure Monitoring (Air/Gas) Kit
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-c—monitoring-devices
/
BZQ
/
K923402
View Source
CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K923402
510(k) Type
Traditional
Applicant
PRO-TECH, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/30/1992
Days to Decision
173 days
Submission Type
Statement