510(k) K852943
K852943 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "NEO SHIELD". The FDA issued a decision of Substantially Equivalent on Nov 8, 1985. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 1985
- Date Received
- Jul 11, 1985
- 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