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FDA 510(k)

SATURN-24HR. HOLTER SCANNER

K-Number: K832772 · 1983-11-03

ApplicantHittman Medical Systems
Decision Date1983-11-03
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SATURN-24HR. HOLTER SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Hittman Medical Systems. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K832772. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATURN-24HR. HOLTER SCANNER?

SATURN-24HR. HOLTER SCANNER is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Hittman Medical Systems. The 510(k) number is K832772.

When did SATURN-24HR. HOLTER SCANNER receive FDA 510(k) clearance?

SATURN-24HR. HOLTER SCANNER received FDA 510(k) clearance on 1983-11-03, under 510(k) number K832772.

Who is the listed applicant for SATURN-24HR. HOLTER SCANNER?

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

What is the FDA product code for SATURN-24HR. HOLTER SCANNER?

The FDA product code for SATURN-24HR. HOLTER SCANNER is DSI.

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Other records listing Hittman Medical Systems 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: DSI)

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

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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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