FDA 510(k)

PFIZER PZ-CT SCANNER

K-Number: K801446 · 1980-07-28

Decision Date1980-07-28

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PFIZER PZ-CT SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Medical Systems, Inc.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801446. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PFIZER PZ-CT SCANNER?

PFIZER PZ-CT SCANNER is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Pfizer Medical Systems, Inc.. The 510(k) number is K801446.

When did PFIZER PZ-CT SCANNER receive FDA 510(k) clearance?

PFIZER PZ-CT SCANNER received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801446.

Who is the listed applicant for PFIZER PZ-CT SCANNER?

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

What is the FDA product code for PFIZER PZ-CT SCANNER?

The FDA product code for PFIZER PZ-CT SCANNER is JAK.

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Other records listing Pfizer Medical Systems, Inc. as applicant

K803032PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.K802530PFIZONIC 250 ULTRASOUND SCANNER K802528PFIZONIC 150 ULTRASOUND SCANNER K802531PFIZONIC 200 ULTRASOUND SCANNER K802529PFIZONIC 100 ULTRASOUND SCANNER K802532PFIZONIC 300 ULTRASOUND SCANNER

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Related Devices (Code: JAK)

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm Corporation K253836FCT iStream Phase 2Fujifilm Corporation K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung Company K253770CardIQ SuiteGE Medical Systems SCS K253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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.