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FDA 510(k)

SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE

K-Number: K924709 · 1996-01-17

ApplicantAir-Shields, Inc.
Decision Date1996-01-17
Product CodeKLK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE is the device name listed in this FDA 510(k) record. The listed applicant is Air-Shields, Inc.. It received FDA 510(k) clearance on 1996-01-17 under 510(k) number K924709. The device is classified under product code KLK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE?

SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE is a medical device that received FDA 510(k) clearance on 1996-01-17. The listed applicant is Air-Shields, Inc.. The 510(k) number is K924709.

When did SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE receive FDA 510(k) clearance?

SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE received FDA 510(k) clearance on 1996-01-17, under 510(k) number K924709.

Who is the listed applicant for SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE?

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

What is the FDA product code for SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE?

The FDA product code for SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE is KLK.

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Other records listing Air-Shields, 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.

K974248WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEMK972309JM-102 JAUNDICE METERK971256DUO-LITE PHOTOTHERAPY SYSTEMK960980ISOLETTE INFANT INCUBATORK940951RW RESUCITAIRE INFANT RADIANT WARMERK940975C450/C400 INFANT INCUBATORS

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Related Devices (Code: KLK)

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.

K003943MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AGK991644MICROGAS 7650 TRANSCUTANEOUS MONITORLinde Medical Sensors AGK980287SIEMENS SC9000/SC9015 TCP02/C02 MODULESiemens Medical Solutions USA, Inc.K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITORAir-Shields Vickers, Inc.K925910HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEHewlett-Packard Co.K893133HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXXMennen Medical, 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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