510(k) K900735
K900735 is an FDA 510(k) premarket notification submitted by Preemicare Corp. for the device "MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR". The FDA issued a decision of Substantially Equivalent on May 2, 1990. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Preemicare Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1990
- Date Received
- February 16, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal
- Device Class
- Class II
- Regulation Number
- 880.5400
- Review Panel
- HO
- Submission Type