FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT BODY TEST
K Number: K853390
·
Decision Feb 5, 1986
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
10
Applicant Total
28
Review Days
176
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Basic Information
- Device Name
- INFANT BODY TEST
- K Number
- K853390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Erich Jaeger, Inc.
- Date Received
- August 13, 1985
- Decision Date
- February 5, 1986
- Product Code
- CCM
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCM | Plethysmograph, Pressure | FDA class 2 | Anesthesiology |
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Other Clearances by Erich Jaeger, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000396 | APNOESCREEN PRO, ALPHA SCREEN PRO | Dec 27, 2000 | Substantially Equivalent |
| K972419 | TOENNIES NEUROSCREEN SYSTEM | Apr 30, 1998 | Substantially Equivalent |
| K960078 | ASTHMA MONITOR | Sep 20, 1996 | Substantially Equivalent |
| K933839 | MASTER SCREEN PNUEMO | Mar 7, 1994 | Substantially Equivalent |
| K932744 | FLOWSCREEN | Mar 7, 1994 | Substantially Equivalent |
| K853443 | ALVEO-DIFFUSION TEST | Feb 21, 1986 | Substantially Equivalent |
| K853409 | SCREENMATE | Feb 5, 1986 | Substantially Equivalent |
| K853434 | ERGO-PNEUMOTEST | Feb 5, 1986 | Substantially Equivalent |
| K853360 | N20 TEST | Sep 3, 1985 | Substantially Equivalent |
| K852337 | PNEUMOSCOPE | Jul 1, 1985 | Substantially Equivalent |