INFANT BODY TEST
FDA 510(k) clearance K853390 · decided 1986-02-05
Clearance details
- K-number
- K853390
- Device name
- INFANT BODY TEST
- Applicant
- Erich Jaeger, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-13
- Decision date
- 1986-02-05
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- CCM
- Device class
- 2
- Regulation number
- 868.1750
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Rockford, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.