The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Startrack Infant Graphics Monitor.
| Device ID | K983274 |
| 510k Number | K983274 |
| Device Name: | STARTRACK INFANT GRAPHICS MONITOR |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
| Contact | David A.c. Green |
| Correspondent | David A.c. Green NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-17 |
| Decision Date | 1998-12-09 |
| Summary: | summary |