The following data is part of a premarket notification filed by Lifestream Int'l, Inc. with the FDA for Tmp Pressure Isolatorr, Tmp Pressure Monitor Syst.
Device ID | K912045 |
510k Number | K912045 |
Device Name: | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST |
Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
Applicant | LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
Contact | Krista Oakes |
Correspondent | Krista Oakes LIFESTREAM INT'L, INC. 2828 N.CRESCENT RIVER DR. The Woodlands, TX 77381 |
Product Code | DXS |
CFR Regulation Number | 870.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-08 |
Decision Date | 1991-10-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B0663014000007 | K912045 | 000 |