FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT
FDA 510(k) clearance K931346 · decided 1993-08-25
Clearance details
- K-number
- K931346
- Device name
- FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT
- Applicant
- Ferno
- Decision
- Substantially Equivalent
- Date received
- 1993-03-17
- Decision date
- 1993-08-25
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- FPL
- Device class
- 2
- Regulation number
- 880.5410
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Wilmington, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.