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FDA 510(k)

FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT

K-Number: K950447 · 1995-02-21

ApplicantVital Signs, Inc.
Decision Date1995-02-21
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1995-02-21 under 510(k) number K950447. 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 FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT?

FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Vital Signs, Inc.. The 510(k) number is K950447.

When did FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT receive FDA 510(k) clearance?

FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT received FDA 510(k) clearance on 1995-02-21, under 510(k) number K950447.

Who is the listed applicant for FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT?

The FDA 510(k) record lists Vital Signs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT?

The FDA product code for FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT is BYD.

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Other records listing Vital Signs, Inc. as applicant

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K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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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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