FDA 510(k)

BrainPulse 1100

K-Nummer: K170926 · 2017-04-28

Entscheidungsdatum2017-04-28

ProduktcodePOP

BeratungsausschussNE

EntscheidungSubstantially Equivalent

Produktübersicht

BrainPulse 1100 is the device name listed in this FDA 510(k) record. The listed applicant is Jan Medical, Inc.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170926. The device is classified under product code POP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the BrainPulse 1100?

BrainPulse 1100 is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Jan Medical, Inc.. The 510(k) number is K170926.

When did BrainPulse 1100 receive FDA 510(k) clearance?

BrainPulse 1100 received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170926.

Who is the listed applicant for BrainPulse 1100?

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

What is the FDA product code for BrainPulse 1100?

The FDA product code for BrainPulse 1100 is POP.

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