FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REBREATHER BAGS
K Number: K940220
·
Decision May 27, 1994
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
18
Applicant Total
4
Review Days
126
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
- REBREATHER BAGS
- K Number
- K940220
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zefon Medical Products
- Date Received
- January 21, 1994
- Decision Date
- May 27, 1994
- 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
PRECISION MED PRODUCTS, LTD. BREATHING 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
BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER
FDA 510(k)
FDA Class 1
·Anesthesiology