FDA 510(k)

CEDARS-SINAI BPGS AND MOCO

K-Number: K010509 · 2001-04-27

Decision Date2001-04-27

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CEDARS-SINAI BPGS AND MOCO is the device name listed in this FDA 510(k) record. The listed applicant is Smv America. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K010509. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDARS-SINAI BPGS AND MOCO?

CEDARS-SINAI BPGS AND MOCO is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Smv America. The 510(k) number is K010509.

When did CEDARS-SINAI BPGS AND MOCO receive FDA 510(k) clearance?

CEDARS-SINAI BPGS AND MOCO received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010509.

Who is the listed applicant for CEDARS-SINAI BPGS AND MOCO?

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

What is the FDA product code for CEDARS-SINAI BPGS AND MOCO?

The FDA product code for CEDARS-SINAI BPGS AND MOCO is KPS.

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Other records listing Smv America as applicant

K003358QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)K002553DS DS I-SERIES K001681POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM K991565TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S K972686VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER K963273VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION

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Related Devices (Code: KPS)

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.