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FDA 510(k)

A10 ULTRASCOPE RECORDER

K-Number: K890142 · 1989-02-06

ApplicantEms Medical, Inc.
Decision Date1989-02-06
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

A10 ULTRASCOPE RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Ems Medical, Inc.. It received FDA 510(k) clearance on 1989-02-06 under 510(k) number K890142. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A10 ULTRASCOPE RECORDER?

A10 ULTRASCOPE RECORDER is a medical device that received FDA 510(k) clearance on 1989-02-06. The listed applicant is Ems Medical, Inc.. The 510(k) number is K890142.

When did A10 ULTRASCOPE RECORDER receive FDA 510(k) clearance?

A10 ULTRASCOPE RECORDER received FDA 510(k) clearance on 1989-02-06, under 510(k) number K890142.

Who is the listed applicant for A10 ULTRASCOPE RECORDER?

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

What is the FDA product code for A10 ULTRASCOPE RECORDER?

The FDA product code for A10 ULTRASCOPE RECORDER is DSF.

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 Ems Medical, 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.

K896306GLOVE N GEL

Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, Inc.

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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