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FDA 510(k)

FIRST BEAT/CARDIO BEAT/CALC

K-Number: K961116 · 1996-08-08

ApplicantMedasonics, Inc.
Decision Date1996-08-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FIRST BEAT/CARDIO BEAT/CALC is the device name listed in this FDA 510(k) record. The listed applicant is Medasonics, Inc.. It received FDA 510(k) clearance on 1996-08-08 under 510(k) number K961116. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRST BEAT/CARDIO BEAT/CALC?

FIRST BEAT/CARDIO BEAT/CALC is a medical device that received FDA 510(k) clearance on 1996-08-08. The listed applicant is Medasonics, Inc.. The 510(k) number is K961116.

When did FIRST BEAT/CARDIO BEAT/CALC receive FDA 510(k) clearance?

FIRST BEAT/CARDIO BEAT/CALC received FDA 510(k) clearance on 1996-08-08, under 510(k) number K961116.

Who is the listed applicant for FIRST BEAT/CARDIO BEAT/CALC?

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

What is the FDA product code for FIRST BEAT/CARDIO BEAT/CALC?

The FDA product code for FIRST BEAT/CARDIO BEAT/CALC is IYO.

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Official Source

View on FDA Database →

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

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