Plethysmograph, Pressure
The Pressure Plethysmograph is an anesthesiology device that measures changes in body part volume using pressure sensing, commonly used to assess respiratory mechanics such as lung volumes and airway resistance by enclosing the patient or body segment in a sealed chamber and detecting pressure fluctuations. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CCM, regulated under 21 CFR 868.1750, within the Anesthesiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CCM
- Device Class
- FDA class 2
- Regulation Number
- 868.1750
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K081823 | MASTERSCREEN PAED - BABY BODY | May 18, 2009 | Substantially Equivalent | Viasys Healthcare GmbH |
| K023796 | MS PAED-BABY BODY | Mar 03, 2003 | Substantially Equivalent | Erich Jaeger GmbH |
| K943259 | 1085 ULTIMATE E PLETHYSMOGRAPH | Apr 10, 1995 | Substantially Equivalent | Medical Graphics Corp. |
| K893420 | MASTERLAB PFT AND MASTERLAB BODY BOX | Jun 23, 1989 | Substantially Equivalent | Quinton, Inc. |
| K853390 | INFANT BODY TEST | Feb 05, 1986 | Substantially Equivalent | Erich Jaeger, Inc. |
| K852102 | COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM | Jul 31, 1985 | Substantially Equivalent | Warren E. Collins, Inc. |
| K852088 | SYSTEM 1085 BODY PLETHYSMOGRAPH | Jul 30, 1985 | Substantially Equivalent | Medical Graphics Corp. |
| K843851 | BODYSCREEN II | Feb 14, 1985 | Substantially Equivalent | Erich Jaeger, Inc. |
| K843846 | UNIVERSAL-BODYTEST | Feb 14, 1985 | Substantially Equivalent | Erich Jaeger, Inc. |
| K791705 | 4200 PNEUMATIC MOUTH SHUTTER | Oct 04, 1979 | Substantially Equivalent | Hans Rudolph, Inc. |
| K772367 | CHEST BELLOWS, SMALL | Jan 11, 1978 | Substantially Equivalent | Honeywell, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.