FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DISPOSABLE 22MM. FLEXIBLE ADAPTOR
K Number: K810621
·
Decision Apr 17, 1981
Classifications
1
FEI Numbers
161
Registration Numbers
161
Same Product Code
93
Applicant Total
17
Review Days
39
Basic Information
- Device Name
- DISPOSABLE 22MM. FLEXIBLE ADAPTOR
- K Number
- K810621
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- INTEC MEDICAL, INC.
- Date Received
- March 9, 1981
- Decision Date
- April 17, 1981
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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