FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOOTY ENDOSCOPE WARMER
K Number: K933515
·
Decision Oct 27, 1993
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
13
Applicant Total
1
Review Days
99
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Basic Information
- Device Name
- BOOTY ENDOSCOPE WARMER
- K Number
- K933515
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- T-Med, Inc.
- Date Received
- July 20, 1993
- Decision Date
- October 27, 1993
- Product Code
- GCI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCI | Laryngoscope, Endoscope | FDA class 2 | Gastroenterology, Urology |
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