FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE
K Number: K853345
·
Decision Oct 1, 1985
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
1
Review Days
50
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Basic Information
- Device Name
- 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE
- K Number
- K853345
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5090
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- 31st. Centruy Medical Corp.
- Date Received
- August 12, 1985
- Decision Date
- October 1, 1985
- Product Code
- BWC
- 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 |
|---|---|---|---|
| BWC | Needle, Emergency Airway | FDA class 2 | Anesthesiology |
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