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FDA 510(k)

TRACH COLLAR

K-Number: K904974 · 1991-01-11

ApplicantRotek Corp.
Decision Date1991-01-11
Product CodeCBH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACH COLLAR is the device name listed in this FDA 510(k) record. The listed applicant is Rotek Corp.. It received FDA 510(k) clearance on 1991-01-11 under 510(k) number K904974. The device is classified under product code CBH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACH COLLAR?

TRACH COLLAR is a medical device that received FDA 510(k) clearance on 1991-01-11. The listed applicant is Rotek Corp.. The 510(k) number is K904974.

When did TRACH COLLAR receive FDA 510(k) clearance?

TRACH COLLAR received FDA 510(k) clearance on 1991-01-11, under 510(k) number K904974.

Who is the listed applicant for TRACH COLLAR?

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

What is the FDA product code for TRACH COLLAR?

The FDA product code for TRACH COLLAR is CBH.

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 Rotek 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.

K872832TRACH COLLAR

Related Devices (Code: CBH)

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.

K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280Dale Medical Products, Inc.K942529HCI TUBE STABILIZERHealth Care Contracts, Inc.K951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSDale Medical Products, Inc.K950930TRACHE-TITEThe Varner Group, Inc.K950318FLEX BLUEKing Systems Corp.K942395ENDOTRACHEAL TUBE HOLDERS.T.I. Medical Products 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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