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FDA 510(k)

SOMNOGUARD SP SOFT

K-Number: K121761 · 2012-09-28

ApplicantTomed Dr. Toussaint GmbH
Decision Date2012-09-28
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOMNOGUARD SP SOFT is the device name listed in this FDA 510(k) record. The listed applicant is Tomed Dr. Toussaint GmbH. It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K121761. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNOGUARD SP SOFT?

SOMNOGUARD SP SOFT is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Tomed Dr. Toussaint GmbH. The 510(k) number is K121761.

When did SOMNOGUARD SP SOFT receive FDA 510(k) clearance?

SOMNOGUARD SP SOFT received FDA 510(k) clearance on 2012-09-28, under 510(k) number K121761.

Who is the listed applicant for SOMNOGUARD SP SOFT?

The FDA 510(k) record lists Tomed Dr. Toussaint GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOMNOGUARD SP SOFT?

The FDA product code for SOMNOGUARD SP SOFT is LRK.

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Other records listing Tomed Dr. Toussaint GmbH 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.

K061688ANTI-SNORING / SLEEP APNEA DEVICE

Related Devices (Code: LRK)

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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