FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25— 510(k) K982228

Substantially Equivalent

Tz Medical, Inc.

FDA 510(k) clearance K982228 for FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25, Substantially Equivalent on 1999-01-14. Applicant: Tz Medical, Inc..

Clearance details

Applicant: Tz Medical, Inc.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 1998-06-25
Decision date: 1999-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

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