FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ERGOTEST 40 & 45
K Number: K843855
·
Decision Nov 27, 1984
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
0
Applicant Total
28
Review Days
57
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ERGOTEST 40 & 45
- K Number
- K843855
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3420
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Erich Jaeger, Inc.
- Date Received
- October 1, 1984
- Decision Date
- November 27, 1984
- Product Code
- ISP
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ISP | Valve, Prosthesis | FDA class 1 | Physical Medicine |
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 |
| 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 |