DeviceClearance

ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP.— 510(k) K022360

Substantially Equivalent

Biotronik, Inc.

FDA 510(k) clearance K022360 for ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP., Substantially Equivalent on 2003-01-27. Applicant: Biotronik, Inc.. Device class: 2.

Clearance details

Applicant
Biotronik, Inc.
Product code
Code DTA
Device class
Class 2
Regulation
21 CFR 870.3720
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Oswego, OR, US
Download summary PDFView on FDA.gov ↗

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