The following data is part of a premarket notification filed by Portable Power Systems, Inc. with the FDA for Battery Pack# S1018la For Ivac 4000, 4200 Vital Check.
Device ID | K932823 |
510k Number | K932823 |
Device Name: | BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PORTABLE POWER SYSTEMS, INC. 1940 TEE LN. Castle Rock, CO 80104 |
Contact | Norman Premo |
Correspondent | Norman Premo PORTABLE POWER SYSTEMS, INC. 1940 TEE LN. Castle Rock, CO 80104 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-09 |
Decision Date | 1994-02-17 |