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FDA 510(k)

SUPERSPIRO

K-Number: K853190 · 1985-09-26

ApplicantCdx Corp.
Decision Date1985-09-26
Product CodeBZM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUPERSPIRO is the device name listed in this FDA 510(k) record. The listed applicant is Cdx Corp.. It received FDA 510(k) clearance on 1985-09-26 under 510(k) number K853190. The device is classified under product code BZM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERSPIRO?

SUPERSPIRO is a medical device that received FDA 510(k) clearance on 1985-09-26. The listed applicant is Cdx Corp.. The 510(k) number is K853190.

When did SUPERSPIRO receive FDA 510(k) clearance?

SUPERSPIRO received FDA 510(k) clearance on 1985-09-26, under 510(k) number K853190.

Who is the listed applicant for SUPERSPIRO?

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

What is the FDA product code for SUPERSPIRO?

The FDA product code for SUPERSPIRO is BZM.

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 Cdx 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.

K842536CDX80K820035CDX 200K820036CXD 400

Related Devices (Code: BZM)

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.

K102229PULMOTRACK 2020 SYSTEMKarmelsonixK090863PERSONAL WHEEZOMETERKarmelsonixK071955WIM-PC, MODEL 1010KarmelsonixK012387STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEMStethographics, Inc.K980878PULMOTRACK,MODEL 1010Karmel Medical Acoustic Technologies , Ltd.K974200ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMOrca Diagnostics Corp.

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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