510(k) K893624
K893624 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "PREEMICARE MODEL 2500 TRANSPORT WARMER". The FDA issued a decision of Substantially Equivalent on September 27, 1989. The device falls under product code FPL (Incubator, Neonatal Transport), a Class II device regulated under 21 CFR 880.5410. Preemicare Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1989
- Date Received
- May 11, 1989
- 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