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FDA 510(k)

PROPEP DELIVERY DEVICE

K-Number: K103200 · 2011-04-12

ApplicantRhythmlink International, LLC
Decision Date2011-04-12
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROPEP DELIVERY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2011-04-12 under 510(k) number K103200. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPEP DELIVERY DEVICE?

PROPEP DELIVERY DEVICE is a medical device that received FDA 510(k) clearance on 2011-04-12. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K103200.

When did PROPEP DELIVERY DEVICE receive FDA 510(k) clearance?

PROPEP DELIVERY DEVICE received FDA 510(k) clearance on 2011-04-12, under 510(k) number K103200.

Who is the listed applicant for PROPEP DELIVERY DEVICE?

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

What is the FDA product code for PROPEP DELIVERY DEVICE?

The FDA product code for PROPEP DELIVERY DEVICE is FMF.

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Related Devices (Code: FMF)

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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