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FDA 510(k)

MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM

K-Number: K033126 · 2003-10-29

ApplicantBehavioral Technology, Inc.
Decision Date2003-10-29
Product CodeLIL
DecisionSubstantially Equivalent

Device Summary

MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Behavioral Technology, Inc.. It received FDA 510(k) clearance on 2003-10-29 under 510(k) number K033126. The device is classified under product code LIL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM?

MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-29. The listed applicant is Behavioral Technology, Inc.. The 510(k) number is K033126.

When did MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM receive FDA 510(k) clearance?

MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM received FDA 510(k) clearance on 2003-10-29, under 510(k) number K033126.

Who is the listed applicant for MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM?

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

What is the FDA product code for MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM?

The FDA product code for MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM is LIL.

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Related Devices (Code: LIL)

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.

K061676RIGIDOMETER, MODEL DIR-4UUroan 21K062042PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM)Plethora SolutionsK052929PREFTEST PROFESSIONAL SUITELimestone Technologies, Inc.K000194DIGITAL INFLECTION RIGIDOMETER (DIR)Uroan Xxi ElectromedicinaK991479VISER PENILE TUMESCENCE MONITORLaborie Medical Tech Corp.K980627NEVA SYSTEMUrometrics, Inc.

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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