The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Instrument Interface Module.
| Device ID | K001265 |
| 510k Number | K001265 |
| Device Name: | WELCH ALLYN INSTRUMENT INTERFACE MODULE |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | David Klementowski |
| Correspondent | David Klementowski WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-19 |
| Decision Date | 2000-07-13 |