510(k) K950680
K950680 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "INFANT HEEL WARMER". The FDA issued a decision of Substantially Equivalent for Some Indications on Aug 23, 1995. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SN (Substantially Equivalent for Some Indications)
- Decision Date
- Aug 23, 1995
- Date Received
- Feb 14, 1995
- 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
- 510(k) Exempt