ESOPHAGEAL MANOMETRY ANALYSIS MODULE— 510(k) K961070
Substantially EquivalentSynectics Medical, Inc.
FDA 510(k) clearance K961070 for ESOPHAGEAL MANOMETRY ANALYSIS MODULE, Substantially Equivalent on 1996-06-11. Applicant: Synectics Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Synectics Medical, Inc.
- Product code
- Code KLA
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
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