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FDA 510(k)

MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO

K-Number: K843580 · 1985-05-28

ApplicantGraphic Controls Corp.
Decision Date1985-05-28
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1985-05-28 under 510(k) number K843580. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO?

MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO is a medical device that received FDA 510(k) clearance on 1985-05-28. The listed applicant is Graphic Controls Corp.. The 510(k) number is K843580.

When did MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO receive FDA 510(k) clearance?

MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO received FDA 510(k) clearance on 1985-05-28, under 510(k) number K843580.

Who is the listed applicant for MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO?

The FDA 510(k) record lists Graphic Controls Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO?

The FDA product code for MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO is DRS.

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Other records listing Graphic Controls Corp. 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.

K981964MEDI-TRACE 4103 NEONATAL ELECTRODEK983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEK972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK964387POINT OF USE II SHARPS-A-GATOR

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Related Devices (Code: DRS)

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

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

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