The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Atlas Monitor.
| Device ID | K984033 |
| 510k Number | K984033 |
| Device Name: | ATLAS MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Zoran I Psenicnki |
| Correspondent | Zoran I Psenicnki WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-12 |
| Decision Date | 1999-07-08 |
| Summary: | summary |