FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIRATOR/GILL 1/SIMV
K Number: K781706
·
Decision Jan 22, 1979
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
14
Applicant Total
4
Review Days
104
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
- RESPIRATOR/GILL 1/SIMV
- K Number
- K781706
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5955
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Chemetron Medical Products, Inc.
- Date Received
- October 10, 1978
- Decision Date
- January 22, 1979
- Product Code
- CBO
- 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 |
|---|---|---|---|
| CBO | Attachment, Intermittent Mandatory Ventilation (Imv) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBO), ordered by most recent decision date.
SIMVAC
FDA 510(k)
FDA Class 2
·Anesthesiology
IMV MANIFOLDS
FDA 510(k)
FDA Class 2
·Anesthesiology
FALL-SAFE IMV #M-511
FDA 510(k)
FDA Class 2
·Anesthesiology
IMV MANIFOLD #M-506
FDA 510(k)
FDA Class 2
·Anesthesiology
IMV W/BAG #M-507
FDA 510(k)
FDA Class 2
·Anesthesiology
IMV W/BAG & HOSES #M-509
FDA 510(k)
FDA Class 2
·Anesthesiology