OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)— 510(k) K952363
Substantially EquivalentEla Medical, Inc.
FDA 510(k) clearance K952363 for OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034), Substantially Equivalent on 1995-08-15. Applicant: Ela Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Ela Medical, Inc.
- Product code
- Code ELA
- Device class
- Class 1
- Regulation
- 21 CFR 872.4565
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.