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FDA 510(k)

BLEASE700/900 SERIES VENTILATORS

K-Number: K112729 · 2012-06-11

ApplicantSpacelabs Healthcare
Decision Date2012-06-11
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BLEASE700/900 SERIES VENTILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare. It received FDA 510(k) clearance on 2012-06-11 under 510(k) number K112729. 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 BLEASE700/900 SERIES VENTILATORS?

BLEASE700/900 SERIES VENTILATORS is a medical device that received FDA 510(k) clearance on 2012-06-11. The listed applicant is Spacelabs Healthcare. The 510(k) number is K112729.

When did BLEASE700/900 SERIES VENTILATORS receive FDA 510(k) clearance?

BLEASE700/900 SERIES VENTILATORS received FDA 510(k) clearance on 2012-06-11, under 510(k) number K112729.

Who is the listed applicant for BLEASE700/900 SERIES VENTILATORS?

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

What is the FDA product code for BLEASE700/900 SERIES VENTILATORS?

The FDA product code for BLEASE700/900 SERIES VENTILATORS is CBK.

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Other records listing Spacelabs Healthcare 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.

K122146XHIBIT CENTRAL STATION, MODEL 96102K130112CAPNO MODULE, 92517K121017CAPNOGRAPHY PAD (92516)K121480ARIATELE TELEMETRY TRANSMITTER (96281)K113051SPACELABS ARKON ANESTHESIA WORKSTATIONK112173SPEACELABS MULTIGAS MODULE

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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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