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FDA 510(k)

MYOPACH ULTRASONIC PACHOMETER

K-Number: K844112 · 1986-01-16

ApplicantMyocure, Inc.
Decision Date1986-01-16
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MYOPACH ULTRASONIC PACHOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Myocure, Inc.. It received FDA 510(k) clearance on 1986-01-16 under 510(k) number K844112. 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 MYOPACH ULTRASONIC PACHOMETER?

MYOPACH ULTRASONIC PACHOMETER is a medical device that received FDA 510(k) clearance on 1986-01-16. The listed applicant is Myocure, Inc.. The 510(k) number is K844112.

When did MYOPACH ULTRASONIC PACHOMETER receive FDA 510(k) clearance?

MYOPACH ULTRASONIC PACHOMETER received FDA 510(k) clearance on 1986-01-16, under 510(k) number K844112.

Who is the listed applicant for MYOPACH ULTRASONIC PACHOMETER?

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

What is the FDA product code for MYOPACH ULTRASONIC PACHOMETER?

The FDA product code for MYOPACH ULTRASONIC PACHOMETER is IYO.

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Other records listing Myocure, Inc. as applicant

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

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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