FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BREATHING BAGS
K Number: K932584
·
Decision Jul 16, 1993
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
18
Applicant Total
178
Review Days
50
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Basic Information
- Device Name
- BREATHING BAGS
- K Number
- K932584
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5320
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Merit Medical Systems, Inc.
- Date Received
- May 27, 1993
- Decision Date
- July 16, 1993
- 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 |
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