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FDA 510(k)

CARDIAC MINISCOPE & MINIGRAPH

K-Number: K780297 · 1978-05-19

ApplicantArco Medical Products Co.
Decision Date1978-05-19
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC MINISCOPE & MINIGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Arco Medical Products Co.. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780297. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC MINISCOPE & MINIGRAPH?

CARDIAC MINISCOPE & MINIGRAPH is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Arco Medical Products Co.. The 510(k) number is K780297.

When did CARDIAC MINISCOPE & MINIGRAPH receive FDA 510(k) clearance?

CARDIAC MINISCOPE & MINIGRAPH received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780297.

Who is the listed applicant for CARDIAC MINISCOPE & MINIGRAPH?

The FDA 510(k) record lists Arco Medical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC MINISCOPE & MINIGRAPH?

The FDA product code for CARDIAC MINISCOPE & MINIGRAPH is DRT.

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Other records listing Arco Medical Products Co. 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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Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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