FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
K Number: K053564
·
Decision Mar 3, 2006
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
3
Review Days
71
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Basic Information
- Device Name
- KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
- K Number
- K053564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penlon Limited
- Date Received
- December 22, 2005
- Decision Date
- March 3, 2006
- Product Code
- CAD
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
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