FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COUPLING/VALVE
K Number: K830399
·
Decision Mar 10, 1983
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
18
Applicant Total
4
Review Days
31
Basic Information
- Device Name
- COUPLING/VALVE
- K Number
- K830399
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- KHI, INC.
- Date Received
- February 7, 1983
- Decision Date
- March 10, 1983
- Product Code
- BTC
- 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 |
|---|---|---|---|
| BTC | Bag, Reservoir | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTC), ordered by most recent decision date.
PeDIA
FDA 510(k)
FDA Class 1
·Anesthesiology
REBREATHER BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRECISION MED PRODUCTS, LTD. BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology