← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MNR — Ventilatory Effort Recorder

DEVICE CLASS
Class II
REGULATION
21 CFR 868.2375
MEDICAL SPECIALTY
Anesthesiology
REVIEW PANEL
AN
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
14
510(K)/PMA CLEARANCES
510k: 14
0
RECALL ENTRIES

Recent clearances

K260050Huneo, LLC · 510k2026-07-15
K253148Vivaquant, Inc. Dba Rhythm Express · 510k2026-06-22
K252628Wesper, Inc. · 510k2026-04-27
K252497Huxley Medical · 510k2025-12-10
K250882Huxley Medical · 510k2025-10-29
K250460Itamar Medical , Ltd. · 510k2025-09-05
K252383Compumedics Limited · 510k2025-08-28
K243220Onera B.V. · 510k2025-07-03

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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