The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Dialysis Sys., Pds 400 & Ro 400.
| Device ID | K781156 |
| 510k Number | K781156 |
| Device Name: | DIALYSIS SYS., PDS 400 & RO 400 |
| Classification | Thin Layer Chromatography, Methamphetamine |
| Applicant | PHYSIO-CONTROL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DJC |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-07-11 |
| Decision Date | 1978-10-24 |