FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APNOESCREEN PRO, ALPHA SCREEN PRO
K Number: K000396
·
Decision Dec 27, 2000
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
28
Review Days
324
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Basic Information
- Device Name
- APNOESCREEN PRO, ALPHA SCREEN PRO
- K Number
- K000396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Erich Jaeger, Inc.
- Date Received
- February 7, 2000
- Decision Date
- December 27, 2000
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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Other Clearances by Erich Jaeger, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K853390 | INFANT BODY TEST | 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 |