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FDA 510(k)

CPR TRACHEOTOMY CARE TRAY

K-Number: K960205 · 1996-08-27

ApplicantCustom Pack Reliability
Decision Date1996-08-27
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CPR TRACHEOTOMY CARE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Custom Pack Reliability. It received FDA 510(k) clearance on 1996-08-27 under 510(k) number K960205. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPR TRACHEOTOMY CARE TRAY?

CPR TRACHEOTOMY CARE TRAY is a medical device that received FDA 510(k) clearance on 1996-08-27. The listed applicant is Custom Pack Reliability. The 510(k) number is K960205.

When did CPR TRACHEOTOMY CARE TRAY receive FDA 510(k) clearance?

CPR TRACHEOTOMY CARE TRAY received FDA 510(k) clearance on 1996-08-27, under 510(k) number K960205.

Who is the listed applicant for CPR TRACHEOTOMY CARE TRAY?

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

What is the FDA product code for CPR TRACHEOTOMY CARE TRAY?

The FDA product code for CPR TRACHEOTOMY CARE TRAY is BTO.

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.

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Other records listing Custom Pack Reliability 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.

K960243CPR C-SECTION DELIVERY PACKK960239CPR D & C TRAYK960216CPR SUCTION CATHETER KITK960213CPR TOTAL HIP PACKK960210CPR ORTHO HAND PACKK960206CPR DRESSING CHANGE TRAY

View all 21 devices →

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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