510(k) K912722
K912722 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HYPER-K HEAT SYSTEM". The FDA issued a decision of Substantially Equivalent on Sep 11, 1991. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 1991
- Date Received
- Jun 18, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pack, Hot Or Cold, Water Circulating
- Device Class
- Class II
- Regulation Number
- 890.5720
- Review Panel
- PM
- Submission Type
- 510(k) Exempt