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FDA 510(k)

PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.

K-Number: K770073 · 1977-01-25

ApplicantRohe Scientific Corp.
Decision Date1977-01-25
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. is the device name listed in this FDA 510(k) record. The listed applicant is Rohe Scientific Corp.. It received FDA 510(k) clearance on 1977-01-25 under 510(k) number K770073. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.?

PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. is a medical device that received FDA 510(k) clearance on 1977-01-25. The listed applicant is Rohe Scientific Corp.. The 510(k) number is K770073.

When did PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. receive FDA 510(k) clearance?

PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. received FDA 510(k) clearance on 1977-01-25, under 510(k) number K770073.

Who is the listed applicant for PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.?

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

What is the FDA product code for PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.?

The FDA product code for PRIMUS INTER PARESECHOCARDIOGRAPHY SYS. is DXK.

Related Clinical Trials

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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Other records listing Rohe Scientific 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.

K810038DIGITAL DIAGNOSTIC ULTRASOUND DEVICE

Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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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