FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXWARMER, MODELS KZ-1 AND KZ-2
K Number: K062644
·
Decision Sep 11, 2007
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
74
Applicant Total
2
Review Days
370
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Basic Information
- Device Name
- FLEXWARMER, MODELS KZ-1 AND KZ-2
- K Number
- K062644
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Merlyn Associates, Inc.
- Date Received
- September 6, 2006
- Decision Date
- September 11, 2007
- Product Code
- LGZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | FDA class 2 | General Hospital |
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Other Clearances by Merlyn Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031794 | ENDOFLEX TRACHEAL TUBE | Mar 12, 2004 | Substantially Equivalent |