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FDA 510(k)

ATYPIA PROFILE MONITOR

K-Number: K770550 · 1977-06-17

ApplicantGeometric Data, Div. Smithkline Corp.
Decision Date1977-06-17
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ATYPIA PROFILE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Geometric Data, Div. Smithkline Corp.. It received FDA 510(k) clearance on 1977-06-17 under 510(k) number K770550. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATYPIA PROFILE MONITOR?

ATYPIA PROFILE MONITOR is a medical device that received FDA 510(k) clearance on 1977-06-17. The listed applicant is Geometric Data, Div. Smithkline Corp.. The 510(k) number is K770550.

When did ATYPIA PROFILE MONITOR receive FDA 510(k) clearance?

ATYPIA PROFILE MONITOR received FDA 510(k) clearance on 1977-06-17, under 510(k) number K770550.

Who is the listed applicant for ATYPIA PROFILE MONITOR?

The FDA 510(k) record lists Geometric Data, Div. Smithkline Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATYPIA PROFILE MONITOR?

The FDA product code for ATYPIA PROFILE MONITOR is GKZ.

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Other records listing Geometric Data, Div. Smithkline Corp. as applicant

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Related Devices (Code: GKZ)

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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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