FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK
K Number: K850309
·
Decision Feb 14, 1985
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
18
Applicant Total
42
Review Days
20
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Basic Information
- Device Name
- COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK
- K Number
- K850309
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5280
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ackrad Laboratories
- Date Received
- January 25, 1985
- Decision Date
- February 14, 1985
- Product Code
- JAY
- 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 |
|---|---|---|---|
| JAY | Support, Breathing Tube | FDA class 1 | Anesthesiology |
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| K915813 | ACKRAD ERCP CONTRAST DELIVERY SET | Mar 11, 1992 | Substantially Equivalent |
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Jul 1, 1991 | Substantially Equivalent |