Laminar P1 (LDH-HW-001)

FDA 510(k) K242487 · Laminar Digital Health, Inc.

Substantially Equivalent

510(k) numberK242487

Submission

Device name
Laminar P1 (LDH-HW-001)
Applicant
Laminar Digital Health, Inc.
Sunnyvale, CA, US
Received
August 21, 2024
Decision date
December 13, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAF – Monitor, Ultrasonic, Nonfetal
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1540
Specialty
Radiology

Other 510(k)s with product code JAF

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K141657THD RevolutionJAF · Traditional Thd Spa02/24/2015SE
K110628SimpleabiJAF · Traditional Newman Medical05/12/2011SE
K093393Lifedop Model 300ABIJAF · Traditional Summit Doppler Systems, Inc.12/24/2009SE
K090009THD Slide OneJAF · Special Thd Spa01/28/2009SE
K081429THD SlideJAF · Traditional Thd Spa07/30/2008SE
K070815THDJAF · Traditional G.F. S.R.L.06/20/2007SE
K063600Vista AvsJAF · Traditional Summit Doppler Systems, Inc.12/19/2006SE
K060064StethofluxJAF · Traditional Odvi04/10/2006SE
K052067Doppler Guided Proctoscope, Model 500HJAF · Traditional Multigon Industries, Inc.08/29/2005SE
K010521Nicolet VersalabJAF · Special Nicolet Biomedical03/09/2001SE

Questions and answers

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

Laminar P1 (LDH-HW-001) (K242487) received a 510(k) decision of Substantially Equivalent on December 13, 2024, 114 days after the submission was received.

What is the product code of K242487?

The FDA product code is JAF – Monitor, Ultrasonic, Nonfetal, a Class II (moderate risk) device regulated under 21 CFR 892.1540.