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FDA 510(k)

HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)

K-Number: K963174 · 1997-03-13

ApplicantDel Mar Avionics
Decision Date1997-03-13
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1997-03-13 under 510(k) number K963174. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)?

HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) is a medical device that received FDA 510(k) clearance on 1997-03-13. The listed applicant is Del Mar Avionics. The 510(k) number is K963174.

When did HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) receive FDA 510(k) clearance?

HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) received FDA 510(k) clearance on 1997-03-13, under 510(k) number K963174.

Who is the listed applicant for HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)?

The FDA 510(k) record lists Del Mar Avionics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)?

The FDA product code for HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) is DSH.

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Other records listing Del Mar Avionics 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: DSH)

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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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