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FDA 510(k)

TYPE 9291 INTERFACE RESPIRATOR

K-Number: K896736 · 1990-02-28

ApplicantS & W Medico Teknik
Decision Date1990-02-28
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TYPE 9291 INTERFACE RESPIRATOR is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1990-02-28 under 510(k) number K896736. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE 9291 INTERFACE RESPIRATOR?

TYPE 9291 INTERFACE RESPIRATOR is a medical device that received FDA 510(k) clearance on 1990-02-28. The listed applicant is S & W Medico Teknik. The 510(k) number is K896736.

When did TYPE 9291 INTERFACE RESPIRATOR receive FDA 510(k) clearance?

TYPE 9291 INTERFACE RESPIRATOR received FDA 510(k) clearance on 1990-02-28, under 510(k) number K896736.

Who is the listed applicant for TYPE 9291 INTERFACE RESPIRATOR?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYPE 9291 INTERFACE RESPIRATOR?

The FDA product code for TYPE 9291 INTERFACE RESPIRATOR is CBK.

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Other records listing S & W Medico Teknik 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.

K9409339267 SPO2 ATHENA MODULEK913013TCPO2 9260 MODULE - SYSTEM ATHENAK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATION

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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