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FDA 510(k)

EDEC-100

K-Number: K843443 · 1985-03-01

ApplicantElectromed Intl., Ltd.
Decision Date1985-03-01
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EDEC-100 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 1985-03-01 under 510(k) number K843443. 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-100?

EDEC-100 is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Electromed Intl., Ltd.. The 510(k) number is K843443.

When did EDEC-100 receive FDA 510(k) clearance?

EDEC-100 received FDA 510(k) clearance on 1985-03-01, under 510(k) number K843443.

Who is the listed applicant for EDEC-100?

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-100?

The FDA product code for EDEC-100 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.

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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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