510(k) K931346
K931346 is an FDA 510(k) premarket notification submitted by Ferno for the device "FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT". The FDA issued a decision of Substantially Equivalent on August 25, 1993. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Ferno has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1993
- Date Received
- March 17, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal Transport
- Device Class
- Class II
- Regulation Number
- 880.5410
- Review Panel
- HO
- Submission Type