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FDA 510(k)

MINI-PECG

K-Number: K832883 · 1983-12-06

ApplicantIntersect Systems, Inc.
Decision Date1983-12-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINI-PECG is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1983-12-06 under 510(k) number K832883. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI-PECG?

MINI-PECG is a medical device that received FDA 510(k) clearance on 1983-12-06. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K832883.

When did MINI-PECG receive FDA 510(k) clearance?

MINI-PECG received FDA 510(k) clearance on 1983-12-06, under 510(k) number K832883.

Who is the listed applicant for MINI-PECG?

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

What is the FDA product code for MINI-PECG?

The FDA product code for MINI-PECG is DPS.

Other records listing Intersect Systems, 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.

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Related Devices (Code: DPS)

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

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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