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FDA 510(k)

MEDI-TRACE DISPOSABLE DOMES/MONITORING

K-Number: K800706 · 1980-04-16

ApplicantGraphic Controls Corp.
Decision Date1980-04-16
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-TRACE DISPOSABLE DOMES/MONITORING 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 1980-04-16 under 510(k) number K800706. 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 DISPOSABLE DOMES/MONITORING?

MEDI-TRACE DISPOSABLE DOMES/MONITORING is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Graphic Controls Corp.. The 510(k) number is K800706.

When did MEDI-TRACE DISPOSABLE DOMES/MONITORING receive FDA 510(k) clearance?

MEDI-TRACE DISPOSABLE DOMES/MONITORING received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800706.

Who is the listed applicant for MEDI-TRACE DISPOSABLE DOMES/MONITORING?

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 DISPOSABLE DOMES/MONITORING?

The FDA product code for MEDI-TRACE DISPOSABLE DOMES/MONITORING is DRS.

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Other records listing Graphic Controls Corp. as applicant

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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

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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