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FDA 510(k)

ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE

K-Number: K950143 · 1995-09-25

ApplicantAstral, Ltd.
Decision Date1995-09-25
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Astral, Ltd.. It received FDA 510(k) clearance on 1995-09-25 under 510(k) number K950143. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE?

ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1995-09-25. The listed applicant is Astral, Ltd.. The 510(k) number is K950143.

When did ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE receive FDA 510(k) clearance?

ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE received FDA 510(k) clearance on 1995-09-25, under 510(k) number K950143.

Who is the listed applicant for ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE?

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

What is the FDA product code for ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE?

The FDA product code for ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE is FMT.

Related Clinical Trials

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Other records listing Astral, Ltd. 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.

K946005ASTRAL DISPOSABLE SKIN TEMPERATURE PROBEK930197KWIK BOARD

Related Devices (Code: FMT)

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.

K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, 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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