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FDA 510(k)

TEMPERATURE PROBE

K-Number: K905148 · 1991-04-01

ApplicantTec II Medical, Inc.
Decision Date1991-04-01
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Tec II Medical, Inc.. It received FDA 510(k) clearance on 1991-04-01 under 510(k) number K905148. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPERATURE PROBE?

TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1991-04-01. The listed applicant is Tec II Medical, Inc.. The 510(k) number is K905148.

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

TEMPERATURE PROBE received FDA 510(k) clearance on 1991-04-01, under 510(k) number K905148.

Who is the listed applicant for TEMPERATURE PROBE?

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

What is the FDA product code for TEMPERATURE PROBE?

The FDA product code for TEMPERATURE PROBE is CAI.

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Other records listing Tec II Medical, 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.

K945657DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER

Related Devices (Code: CAI)

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.

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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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