AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H— 510(k) K945359
Substantially EquivalentArtema Medical AB
FDA 510(k) clearance K945359 for AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H, Substantially Equivalent on 1995-02-21. Applicant: Artema Medical AB. Device class: 1.
Clearance details
- Applicant
- Artema Medical AB
- Product code
- Code BYD
- Device class
- Class 1
- Regulation
- 21 CFR 868.5375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sweden, SE
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