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FDA 510(k)

MANUAL VENTILATION ACCESSORY

K-Number: K854036 · 1985-10-23

ApplicantSiemens Elema AB
Decision Date1985-10-23
Product Code
DecisionSubstantially Equivalent

Device Summary

MANUAL VENTILATION ACCESSORY 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 1985-10-23 under 510(k) number K854036. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL VENTILATION ACCESSORY?

MANUAL VENTILATION ACCESSORY is a medical device that received FDA 510(k) clearance on 1985-10-23. The listed applicant is Siemens Elema AB. The 510(k) number is K854036.

When did MANUAL VENTILATION ACCESSORY receive FDA 510(k) clearance?

MANUAL VENTILATION ACCESSORY received FDA 510(k) clearance on 1985-10-23, under 510(k) number K854036.

Who is the listed applicant for MANUAL VENTILATION ACCESSORY?

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

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Other records listing Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EK010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300A

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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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