510(k) K163295
K163295 is an FDA 510(k) premarket notification submitted by Rapid Aid Corp. for the device "Infant Transport Mattress Warmer with Disc". The FDA issued a decision of Substantially Equivalent on July 24, 2017. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Rapid Aid Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2017
- Date Received
- November 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pack, Hot Or Cold, Disposable
- Device Class
- Class I
- Regulation Number
- 890.5710
- Review Panel
- PM
- Submission Type