Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Laminar P1 (LDH-HW-001)

K-Number: K242487 · 2024-12-13

ApplicantLaminar Digital Health, Inc.
Decision Date2024-12-13
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Laminar P1 (LDH-HW-001) is the device name listed in this FDA 510(k) record. The listed applicant is Laminar Digital Health, Inc.. It received FDA 510(k) clearance on 2024-12-13 under 510(k) number K242487. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laminar P1 (LDH-HW-001)?

Laminar P1 (LDH-HW-001) is a medical device that received FDA 510(k) clearance on 2024-12-13. The listed applicant is Laminar Digital Health, Inc.. The 510(k) number is K242487.

When did Laminar P1 (LDH-HW-001) receive FDA 510(k) clearance?

Laminar P1 (LDH-HW-001) received FDA 510(k) clearance on 2024-12-13, under 510(k) number K242487.

Who is the listed applicant for Laminar P1 (LDH-HW-001)?

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

What is the FDA product code for Laminar P1 (LDH-HW-001)?

The FDA product code for Laminar P1 (LDH-HW-001) is JAF.

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.

↑