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FDA 510(k)

ARIATELE TELEMETRY TRANSMITTER (96281)

K-Number: K121480 · 2012-06-06

ApplicantSpacelabs Healthcare
Decision Date2012-06-06
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARIATELE TELEMETRY TRANSMITTER (96281) is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare. It received FDA 510(k) clearance on 2012-06-06 under 510(k) number K121480. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIATELE TELEMETRY TRANSMITTER (96281)?

ARIATELE TELEMETRY TRANSMITTER (96281) is a medical device that received FDA 510(k) clearance on 2012-06-06. The listed applicant is Spacelabs Healthcare. The 510(k) number is K121480.

When did ARIATELE TELEMETRY TRANSMITTER (96281) receive FDA 510(k) clearance?

ARIATELE TELEMETRY TRANSMITTER (96281) received FDA 510(k) clearance on 2012-06-06, under 510(k) number K121480.

Who is the listed applicant for ARIATELE TELEMETRY TRANSMITTER (96281)?

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

What is the FDA product code for ARIATELE TELEMETRY TRANSMITTER (96281)?

The FDA product code for ARIATELE TELEMETRY TRANSMITTER (96281) is MHX.

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Other records listing Spacelabs Healthcare 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.

K122146XHIBIT CENTRAL STATION, MODEL 96102K130112CAPNO MODULE, 92517K121017CAPNOGRAPHY PAD (92516)K112729BLEASE700/900 SERIES VENTILATORSK113051SPACELABS ARKON ANESTHESIA WORKSTATIONK112173SPEACELABS MULTIGAS MODULE

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Related Devices (Code: MHX)

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.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

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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