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FDA 510(k)

RESP. AIR TEMP. CONTROL & HAZARD MON.

K-Number: K761295 · 1976-12-30

ApplicantHarris-Lake, Inc.
Decision Date1976-12-30
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESP. AIR TEMP. CONTROL & HAZARD MON. is the device name listed in this FDA 510(k) record. The listed applicant is Harris-Lake, Inc.. It received FDA 510(k) clearance on 1976-12-30 under 510(k) number K761295. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESP. AIR TEMP. CONTROL & HAZARD MON.?

RESP. AIR TEMP. CONTROL & HAZARD MON. is a medical device that received FDA 510(k) clearance on 1976-12-30. The listed applicant is Harris-Lake, Inc.. The 510(k) number is K761295.

When did RESP. AIR TEMP. CONTROL & HAZARD MON. receive FDA 510(k) clearance?

RESP. AIR TEMP. CONTROL & HAZARD MON. received FDA 510(k) clearance on 1976-12-30, under 510(k) number K761295.

Who is the listed applicant for RESP. AIR TEMP. CONTROL & HAZARD MON.?

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

What is the FDA product code for RESP. AIR TEMP. CONTROL & HAZARD MON.?

The FDA product code for RESP. AIR TEMP. CONTROL & HAZARD MON. is BZE.

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Other records listing Harris-Lake, Inc. 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.

K761293RESPIRATORY HUMIDIFIERK761294RESPIRATORY BLOWERK760333JAR, COLLECTOR FOR SUCTION SYSTEMSK760317REGULATORS, HIGH SUCTIONK760314FLOWMETER, OXYGENK760316REGULATORS, LOW SUCTION

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Related Devices (Code: BZE)

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.

K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)Vincent Healthcare Products LimitedK253322Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)Medline Industries, LPK243244Heated Breathing TubeGuangdong Eda Technology Co., Ltd.K241268Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron MedicalK234032Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineMedline Industries, LPK222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)Draegerwerk AG & CO Kgaa

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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