FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BERMAN INTUBATING/PHARYNGEAL AIRWAY
K Number: K913680
·
Decision Oct 10, 1991
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
1
Review Days
52
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Basic Information
- Device Name
- BERMAN INTUBATING/PHARYNGEAL AIRWAY
- K Number
- K913680
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chain Plastics Operations, Inc.
- Date Received
- August 19, 1991
- Decision Date
- October 10, 1991
- Product Code
- CAE
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
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