FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROTIME
K Number: K952616
·
Decision Sep 27, 1995
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
9
Review Days
113
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
- MICROTIME
- K Number
- K952616
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Westmed Intl.
- Date Received
- June 6, 1995
- Decision Date
- September 27, 1995
- Product Code
- BTI
- 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 |
|---|---|---|---|
| BTI | Compressor, Air, Portable | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTI), ordered by most recent decision date.
OMBRA TABLE TOP COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDICAL AIR COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DK50 DS
FDA 510(k)
FDA Class 2
·Anesthesiology
EMG TRITON -COMP,MODEL NCA01-XXX SERIES
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDICAL COMPRESSOR, MODELS DK50 D AND DM
FDA 510(k)
FDA Class 2
·Anesthesiology
MINIMATE COMPRESSOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Westmed Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K955047 | WESTMED CIRCULARIE PEP DEVICES | Mar 27, 1996 | Substantially Equivalent |
| K954271 | WESTMED CONDESATE COLLECTION TRAP | Dec 28, 1995 | Substantially Equivalent |
| K953687 | WESTMED PEDIATRIC BACTERIAL/VIRAL FILTER | Sep 18, 1995 | Substantially Equivalent |
| K953506 | WESTMED RESPIRATORY LUER ADAPTOR | Sep 15, 1995 | Substantially Equivalent |
| K951484 | WESTMED BACTERIAL/VIRAL FILTER | Apr 24, 1995 | Substantially Equivalent |
| K945472 | WESTMED PEDIATRIC AND ADULT AEROSOL MASK | Feb 7, 1995 | Substantially Equivalent |
| K924944 | INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA | Jul 2, 1993 | Substantially Equivalent |
| K925173 | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT | Jan 15, 1993 | Substantially Equivalent |