← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
MSX — System, Network And Communication, Physiological Monitors
DEVICE CLASS
Class II
REGULATION
21 CFR 870.2300
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K253654Philips Medizin Systeme Böblingen GmbH · 510k2026-03-30
K243270Tigerconnect · 510k2025-09-30
K242728Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 510k2025-07-31
K242750Nihon Kohden Digital Health Solutions, LLC · 510k2025-06-05
K242842Sibel Health, Inc. · 510k2025-01-08
K241397Hinlab Sas · 510k2024-11-14
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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