The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Endotest Cuff Pressure Monitor.
| Device ID | K951046 |
| 510k Number | K951046 |
| Device Name: | RUSCH ENDOTEST CUFF PRESSURE MONITOR |
| Classification | Cuff, Tracheal Tube, Inflatable |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | BSK |
| CFR Regulation Number | 868.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1995-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704008542 | K951046 | 000 |
| 34026704640745 | K951046 | 000 |
| 44026704554100 | K951046 | 000 |
| 24026704034547 | K951046 | 000 |