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FDA 510(k)

SERVO HUMIDIFIER 153

K-Number: K852601 · 1985-07-08

ApplicantSiemens Elema AB
Decision Date1985-07-08
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SERVO HUMIDIFIER 153 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 1985-07-08 under 510(k) number K852601. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERVO HUMIDIFIER 153?

SERVO HUMIDIFIER 153 is a medical device that received FDA 510(k) clearance on 1985-07-08. The listed applicant is Siemens Elema AB. The 510(k) number is K852601.

When did SERVO HUMIDIFIER 153 receive FDA 510(k) clearance?

SERVO HUMIDIFIER 153 received FDA 510(k) clearance on 1985-07-08, under 510(k) number K852601.

Who is the listed applicant for SERVO HUMIDIFIER 153?

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 SERVO HUMIDIFIER 153?

The FDA product code for SERVO HUMIDIFIER 153 is BYD.

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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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Related Devices (Code: BYD)

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.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

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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