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FDA 510(k)

AB MANUAL VENTILATION ACCESS. 900C

K-Number: K841393 · 1984-05-21

ApplicantSiemens Elema AB
Decision Date1984-05-21
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AB MANUAL VENTILATION ACCESS. 900C is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K841393. 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 AB MANUAL VENTILATION ACCESS. 900C?

AB MANUAL VENTILATION ACCESS. 900C is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Siemens Elema AB. The 510(k) number is K841393.

When did AB MANUAL VENTILATION ACCESS. 900C receive FDA 510(k) clearance?

AB MANUAL VENTILATION ACCESS. 900C received FDA 510(k) clearance on 1984-05-21, under 510(k) number K841393.

Who is the listed applicant for AB MANUAL VENTILATION ACCESS. 900C?

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

What is the FDA product code for AB MANUAL VENTILATION ACCESS. 900C?

The FDA product code for AB MANUAL VENTILATION ACCESS. 900C is CBK.

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Other records listing Siemens Elema AB as applicant

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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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