Cleared Traditional

Laminar P1 (LDH-HW-001)

K242487 · Laminar Digital Health, Inc. · Cardiovascular
Dec 2024
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K242487 is an FDA 510(k) clearance for the Laminar P1 (LDH-HW-001), a Monitor, Ultrasonic, Nonfetal (Class II — Special Controls, product code JAF), submitted by Laminar Digital Health, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 13, 2024, 114 days after receiving the submission on August 21, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 892.1540.

Submission Details

510(k) Number K242487 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2024
Decision Date December 13, 2024
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JAF — Monitor, Ultrasonic, Nonfetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1540