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FDA 510(k)

PANTINO PRO POSITINER

K-Number: K102521 · 2011-03-28

ApplicantSomnomed, Inc.
Decision Date2011-03-28
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANTINO PRO POSITINER is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2011-03-28 under 510(k) number K102521. 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 PANTINO PRO POSITINER?

PANTINO PRO POSITINER is a medical device that received FDA 510(k) clearance on 2011-03-28. The listed applicant is Somnomed, Inc.. The 510(k) number is K102521.

When did PANTINO PRO POSITINER receive FDA 510(k) clearance?

PANTINO PRO POSITINER received FDA 510(k) clearance on 2011-03-28, under 510(k) number K102521.

Who is the listed applicant for PANTINO PRO POSITINER?

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

What is the FDA product code for PANTINO PRO POSITINER?

The FDA product code for PANTINO PRO POSITINER is LRK.

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Other records listing Somnomed, 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.

K261366VirtusK233497Rest Assure SystemK183443SomnoDent AvantK162306SomnoDent ALPHAK130558SOMNODENT HERBST; CLASSIC, FLEXK121340SOMNODENT G2

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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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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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