The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifestat 100.
| Device ID | K853561 |
| 510k Number | K853561 |
| Device Name: | LIFESTAT 100 |
| 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 | Gail Nova |
| Correspondent | Gail Nova 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 | 1985-08-26 |
| Decision Date | 1986-06-09 |