The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Nibp And Co2 Options For The Physio-control Lifepak 12 Defibrillator/monitor System.
| Device ID | K990338 |
| 510k Number | K990338 |
| Device Name: | NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Bob Zito |
| Correspondent | Bob Zito PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-03 |
| Decision Date | 1999-09-01 |
| Summary: | summary |