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FDA 510(k)

MEMOTHERM 10 BABY THERMOMETER

K-Number: K935280 · 1994-10-19

ApplicantInternational Regulatory Consultants
Decision Date1994-10-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEMOTHERM 10 BABY THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is International Regulatory Consultants. It received FDA 510(k) clearance on 1994-10-19 under 510(k) number K935280. 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 MEMOTHERM 10 BABY THERMOMETER?

MEMOTHERM 10 BABY THERMOMETER is a medical device that received FDA 510(k) clearance on 1994-10-19. The listed applicant is International Regulatory Consultants. The 510(k) number is K935280.

When did MEMOTHERM 10 BABY THERMOMETER receive FDA 510(k) clearance?

MEMOTHERM 10 BABY THERMOMETER received FDA 510(k) clearance on 1994-10-19, under 510(k) number K935280.

Who is the listed applicant for MEMOTHERM 10 BABY THERMOMETER?

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

What is the FDA product code for MEMOTHERM 10 BABY THERMOMETER?

The FDA product code for MEMOTHERM 10 BABY THERMOMETER is FLL.

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Other records listing International Regulatory Consultants as applicant

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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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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