510(k) K862921
K862921 is an FDA 510(k) premarket notification submitted by Rotem Industries C/O Medsys, Inc. for the device "MODEL 10200 PREMATURE INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on Apr 1, 1987. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 1, 1987
- Date Received
- Aug 1, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Warmer, Infant Radiant
- Device Class
- Class II
- Regulation Number
- 880.5130
- Review Panel
- HO
- Submission Type
- 510(k)