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 |