K242487 is an FDA 510(k) clearance for the Laminar P1 (LDH-HW-001). This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.1540.
| 510(k) Number | K242487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | JAF - Monitor, Ultrasonic, Nonfetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1540 |