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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 a medical device manufactured by Laminar Digital Health, Inc.. It received FDA 510(k) clearance on 2024-12-13 under approval 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. It is manufactured by Laminar Digital Health, Inc.. The 510(k) number is K242487.

When was Laminar P1 (LDH-HW-001) approved by the FDA?

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

What company makes Laminar P1 (LDH-HW-001)?

Laminar P1 (LDH-HW-001) is manufactured by Laminar Digital Health, Inc..

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.

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