Bodytronic 200

Q: When was Bodytronic 200 cleared by the FDA?

Bodytronic 200 (K123921) received a 510(k) decision of Substantially Equivalent on April 26, 2013, 127 days after the submission was received.

Q: What is the product code of K123921?

The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.

FDA 510(k) K123921 · Bauerfeind AG

Substantially Equivalent

510(k) numberK123921

Submission

Device name: Bodytronic 200
Applicant: Bauerfeind AG
Zeulenroda-Triebes, DE
Received: December 20, 2012
Decision date: April 26, 2013
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.2780
Specialty: Cardiovascular

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Questions and answers

When was Bodytronic 200 cleared by the FDA?

Bodytronic 200 (K123921) received a 510(k) decision of Substantially Equivalent on April 26, 2013, 127 days after the submission was received.

What is the product code of K123921?

The FDA product code is JOM – Plethysmograph, Photoelectric, Pneumatic Or Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 870.2780.