HYPER-K HEAT SYSTEM— 510(k) K912722
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K912722 for HYPER-K HEAT SYSTEM, Substantially Equivalent on 1991-09-11. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code ILO
- Device class
- Class 2
- Regulation
- 21 CFR 890.5720
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
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