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 |