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FDA 510(k)

SURETEMP PLUS

K-Number: K030580 · 2003-05-06

ApplicantWelch Allyn, Inc.
Decision Date2003-05-06
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURETEMP PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2003-05-06 under 510(k) number K030580. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURETEMP PLUS?

SURETEMP PLUS is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K030580.

When did SURETEMP PLUS receive FDA 510(k) clearance?

SURETEMP PLUS received FDA 510(k) clearance on 2003-05-06, under 510(k) number K030580.

Who is the listed applicant for SURETEMP PLUS?

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

What is the FDA product code for SURETEMP PLUS?

The FDA product code for SURETEMP PLUS is FLL.

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Other records listing Welch Allyn, 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.

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Related Devices (Code: FLL)

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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