SLEEP SYSTEM FOR CLINICS & RESEARCH

510(k)K955841AnesthesiologyMNR

COMPUMEDICS PTD LTD. is listed for SLEEP SYSTEM FOR CLINICS & RESEARCH (K955841). The FDA list gives March 11, 1997 as the date of the final decision. The lead panel is Anesthesiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MNR. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K955841

Official FDA database record

Date of final decision: March 11, 1997
Company on the FDA list: COMPUMEDICS PTD LTD.
Lead panel: Anesthesiology
Primary product code: MNR
openFDA device name for the code: Ventilatory Effort Recorder
Device class: 2
Regulation number: 868.2375
openFDA decision description: Unknown
openFDA decision code: SESK
Statement or summary label: Summary