FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERGO-PNEUMOTEST
K Number: K853434
·
Decision Feb 5, 1986
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
28
Review Days
174
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
- ERGO-PNEUMOTEST
- K Number
- K853434
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Erich Jaeger, Inc.
- Date Received
- August 15, 1985
- Decision Date
- February 5, 1986
- Product Code
- BZL
- 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 |
|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZL), ordered by most recent decision date.
Breezing Med
FDA 510(k)
FDA Class 2
·Anesthesiology
NICU V'02
FDA 510(k)
FDA Class 2
·Anesthesiology
ANASCIENT BREATH MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
METAPHOR METABOLIC MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
FITMATE SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
EXPRESS SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K853360 | N20 TEST | Sep 3, 1985 | Substantially Equivalent |
| K852337 | PNEUMOSCOPE | Jul 1, 1985 | Substantially Equivalent |