FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDICOMP INHALANT MASK ELBOW
K Number: K864896
·
Decision Feb 20, 1987
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
23
Review Days
67
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Basic Information
- Device Name
- MEDICOMP INHALANT MASK ELBOW
- K Number
- K864896
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medicomp, Inc.
- Date Received
- December 15, 1986
- Decision Date
- February 20, 1987
- 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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