CCM
11 FDA 510(k) clearances · Product code
110 daysmedian time to decision
278 days90th percentile
11clearances measured
FDA profile
- Official device name
- Plethysmograph, Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1750
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1994: 1 · 1996: 1 · 1998: 1 · 2001: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MASTERSCREEN PAED - BABY BODY (K081823) | Viasys Healthcare GmbH | 2009-05-18 |
| MS PAED-BABY BODY (K023796) | Erich Jaeger GmbH | 2003-03-03 |
| 1085 ULTIMATE E PLETHYSMOGRAPH (K943259) | Medical Graphics Corp. | 1995-04-10 |
| MASTERLAB PFT AND MASTERLAB BODY BOX (K893420) | Quinton, Inc. | 1989-06-23 |
| INFANT BODY TEST (K853390) | Erich Jaeger, Inc. | 1986-02-05 |
| COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM (K852102) | Warren E. Collins, Inc. | 1985-07-31 |
| SYSTEM 1085 BODY PLETHYSMOGRAPH (K852088) | Medical Graphics Corp. | 1985-07-30 |
| UNIVERSAL-BODYTEST (K843846) | Erich Jaeger, Inc. | 1985-02-14 |
| BODYSCREEN II (K843851) | Erich Jaeger, Inc. | 1985-02-14 |
| 4200 PNEUMATIC MOUTH SHUTTER (K791705) | Hans Rudolph, Inc. | 1979-10-04 |
| CHEST BELLOWS, SMALL (K772367) | Honeywell, Inc. | 1978-01-11 |
Track CCM automatically
Every clearance here is in the API, with alerts when new ones post.