FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTILAIR II MEDICAL AIR COMPRESSOR
K Number: K041781
·
Decision Mar 14, 2005
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
73
Applicant Total
30
Review Days
256
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
- VENTILAIR II MEDICAL AIR COMPRESSOR
- K Number
- K041781
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.6250
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hamilton Medical AG
- Date Received
- July 1, 2004
- Decision Date
- March 14, 2005
- 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 Hamilton Medical AG
| K Number | Device Name | ||
|---|---|---|---|
| K201306 | HAMILTON-C3 | Feb 5, 2021 | Substantially Equivalent |
| K201658 | Hamilton-C6 | Dec 11, 2020 | Substantially Equivalent |
| K193228 | Hamilton-G5 | May 4, 2020 | Substantially Equivalent |
| K181216 | HAMILTON-T1, HAMILTON-C1 | Aug 2, 2019 | Substantially Equivalent |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | Sep 20, 2017 | Substantially Equivalent |
| K161450 | HAMILTON-C3 | Apr 27, 2017 | Substantially Equivalent |
| K153046 | HAMILTON-MR1 | Sep 6, 2016 | Substantially Equivalent |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | May 3, 2016 | Substantially Equivalent |
| K150893 | IntelliCuff | Jan 29, 2016 | Substantially Equivalent |
| K140939 | HAMILTON-T1,HAMILTON-C1 | Sep 2, 2015 | Substantially Equivalent |