GOLDEN THERMAL(R)— 510(k) K914182
Substantially EquivalentSeabrook Medical Systems, Inc.
FDA 510(k) clearance K914182 for GOLDEN THERMAL(R), Substantially Equivalent on 1991-10-18. Applicant: Seabrook Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Seabrook Medical Systems, Inc.
- 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
- Cincinnati, OH, US
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