FDA 510(k)

PACEMAKER PATIENT ADAPTOR MODULE (PPAM)

K-Number: K900213 · 1990-06-28

Decision Date1990-06-28

Product CodeDSB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PACEMAKER PATIENT ADAPTOR MODULE (PPAM) is the device name listed in this FDA 510(k) record. The listed applicant is Bomed Medical Mfg., Ltd.. It received FDA 510(k) clearance on 1990-06-28 under 510(k) number K900213. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACEMAKER PATIENT ADAPTOR MODULE (PPAM)?

PACEMAKER PATIENT ADAPTOR MODULE (PPAM) is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Bomed Medical Mfg., Ltd.. The 510(k) number is K900213.

When did PACEMAKER PATIENT ADAPTOR MODULE (PPAM) receive FDA 510(k) clearance?

PACEMAKER PATIENT ADAPTOR MODULE (PPAM) received FDA 510(k) clearance on 1990-06-28, under 510(k) number K900213.

Who is the listed applicant for PACEMAKER PATIENT ADAPTOR MODULE (PPAM)?

The FDA 510(k) record lists Bomed Medical Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACEMAKER PATIENT ADAPTOR MODULE (PPAM)?

The FDA product code for PACEMAKER PATIENT ADAPTOR MODULE (PPAM) is DSB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.