The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Walkaway Tm 40.
| Device ID | K911400 |
| 510k Number | K911400 |
| Device Name: | WALKAWAY TM 40 |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | BAXTER HEALTHCARE CORP. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Contact | Karla Tomfohrde |
| Correspondent | Karla Tomfohrde BAXTER HEALTHCARE CORP. 1584 ENTERPRISE BLVD. West Sacramento, CA 95691 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-29 |
| Decision Date | 1991-11-19 |