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FDA 510(k)

EDEC 2000

K-Number: K852908 · 1985-11-29

ApplicantElectromed Intl., Ltd.
Decision Date1985-11-29
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EDEC 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Electromed Intl., Ltd.. It received FDA 510(k) clearance on 1985-11-29 under 510(k) number K852908. 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 EDEC 2000?

EDEC 2000 is a medical device that received FDA 510(k) clearance on 1985-11-29. The listed applicant is Electromed Intl., Ltd.. The 510(k) number is K852908.

When did EDEC 2000 receive FDA 510(k) clearance?

EDEC 2000 received FDA 510(k) clearance on 1985-11-29, under 510(k) number K852908.

Who is the listed applicant for EDEC 2000?

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

What is the FDA product code for EDEC 2000?

The FDA product code for EDEC 2000 is IZO.

Other records listing Electromed Intl., Ltd. 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.

K003688VIEW READING STATIONK000474VIEW NTK990759VIEW COMK974255CD-R STATION AND VRS-2000K971176VIEW ARCHIVING STATIONK950694COMPACT-X

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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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