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FDA 510(k)

PETIT SOPHIA

K-Number: K021978 · 2003-04-08

ApplicantNishitomo Co., Inc.
Decision Date2003-04-08
Product CodeLHD
DecisionSubstantially Equivalent

Device Summary

PETIT SOPHIA is the device name listed in this FDA 510(k) record. The listed applicant is Nishitomo Co., Inc.. It received FDA 510(k) clearance on 2003-04-08 under 510(k) number K021978. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PETIT SOPHIA?

PETIT SOPHIA is a medical device that received FDA 510(k) clearance on 2003-04-08. The listed applicant is Nishitomo Co., Inc.. The 510(k) number is K021978.

When did PETIT SOPHIA receive FDA 510(k) clearance?

PETIT SOPHIA received FDA 510(k) clearance on 2003-04-08, under 510(k) number K021978.

Who is the listed applicant for PETIT SOPHIA?

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

What is the FDA product code for PETIT SOPHIA?

The FDA product code for PETIT SOPHIA is LHD.

Related Clinical Trials

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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Other records listing Nishitomo Co., 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.

K901512L SOPHIA

Related Devices (Code: LHD)

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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