GIRAFFE AND PANDA WARMERS
FDA 510(k) clearance K123309 · decided 2013-02-05
Clearance details
- K-number
- K123309
- Device name
- GIRAFFE AND PANDA WARMERS
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 2012-10-24
- Decision date
- 2013-02-05
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Laurel, MD, US
- Third-party review
- No
- Expedited review
- No
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