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FDA 510(k)

TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)

K-Number: K924193 · 1993-06-16

ApplicantAmerican Healthcare Corp.
Decision Date1993-06-16
Product CodeBTO
Advisory CommitteeAN
DecisionUnknown

Device Summary

TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) is the device name listed in this FDA 510(k) record. The listed applicant is American Healthcare Corp.. It received FDA 510(k) clearance on 1993-06-16 under 510(k) number K924193. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)?

TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) is a medical device that received FDA 510(k) clearance on 1993-06-16. The listed applicant is American Healthcare Corp.. The 510(k) number is K924193.

When did TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) receive FDA 510(k) clearance?

TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) received FDA 510(k) clearance on 1993-06-16, under 510(k) number K924193.

Who is the listed applicant for TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)?

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

What is the FDA product code for TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)?

The FDA product code for TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685) is BTO.

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Other records listing American Healthcare 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.

K924192I.V. START KIT (AHC-50-54954K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEK923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERK923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEK923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERK924191TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL

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Related Devices (Code: BTO)

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.

K253063Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series)Vitaltec CorporationK2429215300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mmVitaltec CorporationK233713Pilling Tracheostomy TubesTeleflex MedicalK192511Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mmVenner Medical (Singapore) Pte, Ltd.K173384BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tubeSmiths Medical Ads, Inc.K120079PRIMED TRACHEOSTOMY TUBES (MULTIPLE)Primed Halberstadt Medizintechnik GmbH

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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