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FDA 510(k)

DALE COMBO TRACHEOSTOMY TUBE HOLDER

K-Number: K812429 · 1981-09-23

ApplicantDale Medical Products, Inc.
Decision Date1981-09-23
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DALE COMBO TRACHEOSTOMY TUBE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Dale Medical Products, Inc.. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812429. The device is classified under product code EQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DALE COMBO TRACHEOSTOMY TUBE HOLDER?

DALE COMBO TRACHEOSTOMY TUBE HOLDER is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Dale Medical Products, Inc.. The 510(k) number is K812429.

When did DALE COMBO TRACHEOSTOMY TUBE HOLDER receive FDA 510(k) clearance?

DALE COMBO TRACHEOSTOMY TUBE HOLDER received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812429.

Who is the listed applicant for DALE COMBO TRACHEOSTOMY TUBE HOLDER?

The FDA 510(k) record lists Dale Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DALE COMBO TRACHEOSTOMY TUBE HOLDER?

The FDA product code for DALE COMBO TRACHEOSTOMY TUBE HOLDER is EQH.

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Other records listing Dale Medical Products, Inc. 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.

K082241THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751K994300NASOGASTRIC TUBE HOLDER, MODEL 160K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280K961693DALE GASTROSTOMY TUBE HOLDERK951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSK914245DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)

View all 13 devices →

Related Devices (Code: EQH)

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.

K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KGK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, 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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