The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Spot Vital Sign Monitor With Mp506.
| Device ID | K022163 |
| 510k Number | K022163 |
| Device Name: | WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-03 |
| Decision Date | 2002-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00732094026313 | K022163 | 000 |
| 00732094026092 | K022163 | 000 |
| 00732094022865 | K022163 | 000 |
| 00732094022858 | K022163 | 000 |