FDA Product Code MNR: Ventilatory Effort Recorder
Leading manufacturers include Huxley Medical, Itamar Medical , Ltd. and Compumedics Limited.
FDA 510(k) Cleared Ventilatory Effort Recorder Devices (Product Code MNR)
About Product Code MNR - Regulatory Context
510(k) Submission Activity
161 total 510(k) submissions under product code MNR since 1995, with 161 receiving FDA clearance (average review time: 200 days).
Submission volume has increased in recent years - 16 submissions in the last 24 months compared to 11 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for MNR submissions have been consistent, averaging 190 days recently vs 201 days historically.
MNR devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →