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FDA 510(k)

TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE

K-Number: K820307 · 1982-03-05

ApplicantTecnomed, Inc.
Decision Date1982-03-05
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE is the device name listed in this FDA 510(k) record. The listed applicant is Tecnomed, Inc.. It received FDA 510(k) clearance on 1982-03-05 under 510(k) number K820307. 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 TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE?

TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE is a medical device that received FDA 510(k) clearance on 1982-03-05. The listed applicant is Tecnomed, Inc.. The 510(k) number is K820307.

When did TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE receive FDA 510(k) clearance?

TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE received FDA 510(k) clearance on 1982-03-05, under 510(k) number K820307.

Who is the listed applicant for TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE?

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

What is the FDA product code for TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE?

The FDA product code for TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE is IZO.

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Other records listing Tecnomed, Inc. 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.

K892226TEC 6340 90/15 RADIOGRAPHIC/FLUOROSCOPIC TABLEK854203TEC 2720 MAMEX DC MAGK820306RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHICK827126TECHNOMED GENERATOR, RADIOGRAPHIC, 3 PHASEK827124RALCO COLLIMATOR, AUTOMATIC, RADIOGRAPHICK820305RALCO COLLIMATORS, MANUAL RADIOGRAPHIC

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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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