The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Modified Baromed Breathing Pressure Monitor.
| Device ID | K861720 |
| 510k Number | K861720 |
| Device Name: | MODIFIED BAROMED BREATHING PRESSURE MONITOR |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Contact | Edward T Griffith |
| Correspondent | Edward T Griffith DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-05 |
| Decision Date | 1986-05-09 |