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FDA 510(k)

DALE ENDOTRACHEAL TUBE HOLDER 270/280

K-Number: K964399 · 1997-01-28

ApplicantDale Medical Products, Inc.
Decision Date1997-01-28
Product CodeCBH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DALE ENDOTRACHEAL TUBE HOLDER 270/280 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 1997-01-28 under 510(k) number K964399. 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 DALE ENDOTRACHEAL TUBE HOLDER 270/280?

DALE ENDOTRACHEAL TUBE HOLDER 270/280 is a medical device that received FDA 510(k) clearance on 1997-01-28. The listed applicant is Dale Medical Products, Inc.. The 510(k) number is K964399.

When did DALE ENDOTRACHEAL TUBE HOLDER 270/280 receive FDA 510(k) clearance?

DALE ENDOTRACHEAL TUBE HOLDER 270/280 received FDA 510(k) clearance on 1997-01-28, under 510(k) number K964399.

Who is the listed applicant for DALE ENDOTRACHEAL TUBE HOLDER 270/280?

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 ENDOTRACHEAL TUBE HOLDER 270/280?

The FDA product code for DALE ENDOTRACHEAL TUBE HOLDER 270/280 is CBH.

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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 160K961693DALE GASTROSTOMY TUBE HOLDERK951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSK914245DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)K905231DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.

View all 13 devices →

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.

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.K934288HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BARNeo-Tech, 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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