FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BICORE SMARTCATH INTRATRACHEAL CATHETER
K Number: K935788
·
Decision Jul 3, 1995
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
13
Applicant Total
4
Review Days
574
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Basic Information
- Device Name
- BICORE SMARTCATH INTRATRACHEAL CATHETER
- K Number
- K935788
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bicore Monitoring Systems
- Date Received
- December 6, 1993
- Decision Date
- July 3, 1995
- Product Code
- MOD
- 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 |
|---|---|---|---|
| MOD | Accessory To Continuous Ventilator (Respirator) | FDA class 2 | Anesthesiology |
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