OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)— 510(k) K952363

Substantially Equivalent

Ela 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..

Clearance details

Applicant: Ela Medical, Inc.
Product code: Code ELA
Advisory panel: Dental
Date received: 1995-05-01
Decision date: 1995-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

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