The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Patient Monitor #404.
| Device ID | K831319 |
| 510k Number | K831319 |
| Device Name: | PATIENT MONITOR #404 |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | ANALOGIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-22 |
| Decision Date | 1984-03-22 |