FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVA-MIST PORTABLE AIR COMPRESSOR
K Number: K844956
·
Decision Feb 14, 1985
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
5
Review Days
55
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
- AVA-MIST PORTABLE AIR COMPRESSOR
- K Number
- K844956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Avatron, Inc.
- Date Received
- December 21, 1984
- Decision Date
- February 14, 1985
- 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 Avatron, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K851193 | ANESTHESIA BREATHING CIRCUIT | Jun 14, 1985 | Substantially Equivalent |
| K843102 | AVA-NEB NEBULIZER | Aug 17, 1984 | Substantially Equivalent |
| K842778 | AVATRON UNIVERSAL ADULT VOL. VENTILATOR | Jul 26, 1984 | Substantially Equivalent |
| K842389 | AVATRON DISPOSABLE I.P.P.B. CIRUCIT | Jun 26, 1984 | Substantially Equivalent |