The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Ambulatory Blood Pressure Monitor, Mdl# 5100-01.
| Device ID | K925899 |
| 510k Number | K925899 |
| Device Name: | AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 |
| Classification | Computer, Blood-pressure |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | John Watkins |
| Correspondent | John Watkins WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-20 |
| Decision Date | 1993-05-21 |