FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOWSCREEN
K Number: K932744
·
Decision Mar 7, 1994
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
28
Review Days
272
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
- FLOWSCREEN
- K Number
- K932744
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Erich Jaeger, Inc.
- Date Received
- June 8, 1993
- Decision Date
- March 7, 1994
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTY), ordered by most recent decision date.
Ascent Cardiorespiratory Diagnostic Software
FDA 510(k)
FDA Class 2
·Anesthesiology
SpiroSphere, SpiroSphereECG, CardioSphere
FDA 510(k)
FDA Class 2
·Anesthesiology
Pulmonary Function Tester, Model: A9
FDA 510(k)
FDA Class 2
·Anesthesiology
Virtus Metabolic Monitor
FDA 510(k)
FDA Class 2
·Anesthesiology
Model 9100 PFT/DICO
FDA 510(k)
FDA Class 2
·Anesthesiology
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
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 |
| 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 |