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FDA 510(k)

PROCESS 100 ST

K-Number: K833846 · 1983-12-16

ApplicantCgr Medical Corp.
Decision Date1983-12-16
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROCESS 100 ST is the device name listed in this FDA 510(k) record. The listed applicant is Cgr Medical Corp.. It received FDA 510(k) clearance on 1983-12-16 under 510(k) number K833846. The device is classified under product code IZO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROCESS 100 ST?

PROCESS 100 ST is a medical device that received FDA 510(k) clearance on 1983-12-16. The listed applicant is Cgr Medical Corp.. The 510(k) number is K833846.

When did PROCESS 100 ST receive FDA 510(k) clearance?

PROCESS 100 ST received FDA 510(k) clearance on 1983-12-16, under 510(k) number K833846.

Who is the listed applicant for PROCESS 100 ST?

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

What is the FDA product code for PROCESS 100 ST?

The FDA product code for PROCESS 100 ST is IZO.

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Other records listing Cgr Medical Corp. 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.

K843926PRESTILIX 1690K843235STENOSCOPK843985SUSPENSION 7K841649MAXIMAX - 4K833223SONEL 3000AK833941ORION

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Related Devices (Code: IZO)

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.

K954666MPH50, MPH65, AND MPH80GE Medical SystemsK953582HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATORVarian Canada, Inc.K953831N 800 HFNucletron-Oldelft Corp.K952822SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150GShimadzu Corp.K952265MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATORControl-X, Inc.K950883POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.

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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