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FDA 510(k)

PINNACLE 3

K-Number: K926008 · 1994-10-04

ApplicantAdac Laboratories
Decision Date1994-10-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PINNACLE 3 is the device name listed in this FDA 510(k) record. The listed applicant is Adac Laboratories. It received FDA 510(k) clearance on 1994-10-04 under 510(k) number K926008. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PINNACLE 3?

PINNACLE 3 is a medical device that received FDA 510(k) clearance on 1994-10-04. The listed applicant is Adac Laboratories. The 510(k) number is K926008.

When did PINNACLE 3 receive FDA 510(k) clearance?

PINNACLE 3 received FDA 510(k) clearance on 1994-10-04, under 510(k) number K926008.

Who is the listed applicant for PINNACLE 3?

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

What is the FDA product code for PINNACLE 3?

The FDA product code for PINNACLE 3 is IYE.

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Other records listing Adac Laboratories 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: IYE)

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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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