Pacemaker Patient Adaptor Module (Ppam)

FDA 510(k) K900213 · Bomed Medical Mfg., Ltd.

Substantially Equivalent

510(k) numberK900213

Submission

Device name
Pacemaker Patient Adaptor Module (Ppam)
Applicant
Bomed Medical Mfg., Ltd.
Irvine, CA, US
Received
January 17, 1990
Decision date
June 28, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DSB – Plethysmograph, Impedance
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

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More from Zynex Medical, Inc.

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Questions and answers

When was Pacemaker Patient Adaptor Module (Ppam) cleared by the FDA?

Pacemaker Patient Adaptor Module (Ppam) (K900213) received a 510(k) decision of Substantially Equivalent on June 28, 1990, 162 days after the submission was received.

What is the product code of K900213?

The FDA product code is DSB – Plethysmograph, Impedance, a Class II (moderate risk) device regulated under 21 CFR 870.2770.