AHCS HEMOPERFUSION SYSTEM— 510(k) K971015
Substantially EquivalentAmerican Health Care Systems, Inc.
FDA 510(k) clearance K971015 for AHCS HEMOPERFUSION SYSTEM, Substantially Equivalent on 1997-10-22. Applicant: American Health Care Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- American Health Care Systems, Inc.
- Product code
- Code FLD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5870
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Metairie, LA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.