CCM · Plethysmograph, Pressure
Anesthesiology · 21 CFR 868.1750 · Class 2
Overview
| Product Code | CCM |
|---|---|
| Device Name | Plethysmograph, Pressure |
| Regulation | 21 CFR 868.1750 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A pressure plethysmograph is a device used to determine a patient's airway resistance and lung volumes by measuring pressure changes while the patient is in an airtight box.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081823 | MASTERSCREEN PAED - BABY BODY | Viasys Healthcare GmbH | May 18, 2009 | SESE |
| K023796 | MS PAED-BABY BODY | Erich Jaeger GmbH | Mar 3, 2003 | SESE |
| K943259 | 1085 ULTIMATE E PLETHYSMOGRAPH | Medical Graphics Corp. | Apr 10, 1995 | SESE |
| K893420 | MASTERLAB PFT AND MASTERLAB BODY BOX | Quinton, Inc. | Jun 23, 1989 | SESE |
| K853390 | INFANT BODY TEST | Erich Jaeger, Inc. | Feb 5, 1986 | SESE |
| K852102 | COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM | Warren E. Collins, Inc. | Jul 31, 1985 | SESE |
| K852088 | SYSTEM 1085 BODY PLETHYSMOGRAPH | Medical Graphics Corp. | Jul 30, 1985 | SESE |
| K843851 | BODYSCREEN II | Erich Jaeger, Inc. | Feb 14, 1985 | SESE |
| K843846 | UNIVERSAL-BODYTEST | Erich Jaeger, Inc. | Feb 14, 1985 | SESE |
| K791705 | 4200 PNEUMATIC MOUTH SHUTTER | Hans Rudolph, Inc. | Oct 4, 1979 | SESE |
| K772367 | CHEST BELLOWS, SMALL | Honeywell, Inc. | Jan 11, 1978 | SESE |
Top Applicants
- Erich Jaeger, Inc. — 3 clearances
- Medical Graphics Corp. — 2 clearances
- Warren E. Collins, Inc. — 1 clearance
- Viasys Healthcare GmbH — 1 clearance
- Quinton, Inc. — 1 clearance
