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FDA 510(k)

BITESTRIP

K-Number: K030869 · 2004-05-14

ApplicantS.L.P. , Ltd.
Decision Date2004-05-14
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BITESTRIP is the device name listed in this FDA 510(k) record. The listed applicant is S.L.P. , Ltd.. It received FDA 510(k) clearance on 2004-05-14 under 510(k) number K030869. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BITESTRIP?

BITESTRIP is a medical device that received FDA 510(k) clearance on 2004-05-14. The listed applicant is S.L.P. , Ltd.. The 510(k) number is K030869.

When did BITESTRIP receive FDA 510(k) clearance?

BITESTRIP received FDA 510(k) clearance on 2004-05-14, under 510(k) number K030869.

Who is the listed applicant for BITESTRIP?

The FDA 510(k) record lists S.L.P. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BITESTRIP?

The FDA product code for BITESTRIP is KZM.

Related Clinical Trials

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Other records listing S.L.P. , Ltd. 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.

K191574OxSAT 100K112822SLEEPSTRIP IIK080375RMX PHYSIOLOGICAL DATA RECORDERK042253SLEEPSENSE SLEEP SENSORS

Related Devices (Code: KZM)

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.

K161716TEETHAN 2.0Bts S.P.A.K130158M-SCANBio-Research Associates, Inc.K113677GRINDCARE MEASUREMedotech A/SK082927BIOEMG IIIBio-Research Associates, Inc.K043373DOLOTENS DENTAL TM 1Neuromuscular Technologies, Inc.K003176BIOEMG II AND BIOJVABio-Research Associates, Inc.

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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