510(k) K871594
K871594 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "BIRTHING ROOM WARMER". The FDA issued a decision of Substantially Equivalent on Jun 5, 1987. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Air-Shields, Inc. has 32 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 1987
- Date Received
- Apr 24, 1987
- 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)