FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
KZM
Device, Muscle Monitoring
2
Product Code
K
16
1716
TEETHAN 2.0
2
Cleared 510(K)
K
13
0158
M-SCAN
2
Cleared 510(K)
K
11
3677
GRINDCARE MEASURE
2
Cleared 510(K)
K
08
2927
BIOEMG III
2
Cleared 510(K)
K
04
3373
DOLOTENS DENTAL TM 1
2
Cleared 510(K)
K
03
0869
BITESTRIP
2
Cleared 510(K)
K
00
3176
BIOEMG II AND BIOJVA
2
Cleared 510(K)
K
00
3287
MODEL K7 EVALUATION DEVICE
2
Cleared 510(K)
K
99
2694
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
2
Cleared 510(K)
K
98
1563
BIOPAK MEASUREMENT SYSTEM
2
Cleared 510(K)
Show All 19 Submissions
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
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 30 November 2024 at 11:09 am
DE
/
subpart-b—physical-medicine-diagnostic-devices
/
KZM
/
K003176
View Source
BIOEMG II AND BIOJVA
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003176
510(k) Type
Traditional
Applicant
BIO-RESEARCH ASSOCIATES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/2001
Days to Decision
85 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
KZM
Device, Muscle Monitoring
K
16
1716
TEETHAN 2.0
K
13
0158
M-SCAN
K
11
3677
GRINDCARE MEASURE
K
08
2927
BIOEMG III
K
04
3373
DOLOTENS DENTAL TM 1
K
03
0869
BITESTRIP
K
00
3176
BIOEMG II AND BIOJVA
K
00
3287
MODEL K7 EVALUATION DEVICE
K
99
2694
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
K
98
1563
BIOPAK MEASUREMENT SYSTEM
Show All 19 Submissions
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
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
DE
/
subpart-b—physical-medicine-diagnostic-devices
/
KZM
/
K003176
View Source
BIOEMG II AND BIOJVA
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K003176
510(k) Type
Traditional
Applicant
BIO-RESEARCH ASSOCIATES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/4/2001
Days to Decision
85 days
Submission Type
Statement