510(k) K812683
K812683 is an FDA 510(k) premarket notification submitted by Pharmaquest Corp. for the device "NEONATE FLEXFLOAT". The FDA issued a decision of Substantially Equivalent on October 13, 1981. The device falls under product code FOH (Mattress, Water, Temperature Regulated), a Class I device regulated under 21 CFR 880.5560. Pharmaquest Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1981
- Date Received
- September 22, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mattress, Water, Temperature Regulated
- Device Class
- Class I
- Regulation Number
- 880.5560
- Review Panel
- HO
- Submission Type