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FDA 510(k)

SURETEMP

K-Number: K964643 · 1997-01-09

ApplicantDiatek Instruments, Inc.
Decision Date1997-01-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURETEMP is the device name listed in this FDA 510(k) record. The listed applicant is Diatek Instruments, Inc.. It received FDA 510(k) clearance on 1997-01-09 under 510(k) number K964643. 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?

SURETEMP is a medical device that received FDA 510(k) clearance on 1997-01-09. The listed applicant is Diatek Instruments, Inc.. The 510(k) number is K964643.

When did SURETEMP receive FDA 510(k) clearance?

SURETEMP received FDA 510(k) clearance on 1997-01-09, under 510(k) number K964643.

Who is the listed applicant for SURETEMP?

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

What is the FDA product code for SURETEMP?

The FDA product code for SURETEMP is FLL.

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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

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