FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CBG CUFF MANOMETER
K Number: K873614
·
Decision Jan 22, 1988
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
38
Applicant Total
14
Review Days
136
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Basic Information
- Device Name
- CBG CUFF MANOMETER
- K Number
- K873614
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Med Devices, Inc.
- Date Received
- September 8, 1987
- Decision Date
- January 22, 1988
- Product Code
- BSK
- 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 |
|---|---|---|---|
| BSK | Cuff, Tracheal Tube, Inflatable | FDA class 2 | Anesthesiology |
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Cuffix
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FDA Class 2
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