510(k) K901332

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE by Biotronik, GmbH & Co. — Product Code DTC

K901332 is an FDA 510(k) premarket notification submitted by Biotronik, GmbH & Co. for the device "PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE". The FDA issued a decision of Substantially Equivalent on May 9, 1990. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Biotronik, GmbH & Co. has at least 10 other 510(k) clearances on record.