Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COMPACT-X

K-Number: K950694 · 1995-03-31

ApplicantElectromed Intl., Ltd.
Decision Date1995-03-31
Product CodeIZO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPACT-X 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 1995-03-31 under 510(k) number K950694. 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 COMPACT-X?

COMPACT-X is a medical device that received FDA 510(k) clearance on 1995-03-31. The listed applicant is Electromed Intl., Ltd.. The 510(k) number is K950694.

When did COMPACT-X receive FDA 510(k) clearance?

COMPACT-X received FDA 510(k) clearance on 1995-03-31, under 510(k) number K950694.

Who is the listed applicant for COMPACT-X?

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 COMPACT-X?

The FDA product code for COMPACT-X is IZO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 STATIONK880050EDEC 60R

View all 23 devices →

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.

↑