The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifestat 1600 Printer.
Device ID | K881346 |
510k Number | K881346 |
Device Name: | LIFESTAT 1600 PRINTER |
Classification | Recorder, Paper Chart |
Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
Contact | Sherri L Pocock |
Correspondent | Sherri L Pocock PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-30 |
Decision Date | 1988-06-09 |