The following data is part of a premarket notification filed by Nspire Health, Inc. with the FDA for Wright Respirometer, Mark 8, And 14 Respirometer, Model 700-021, 700-008, 700-014.
| Device ID | K091853 |
| 510k Number | K091853 |
| Device Name: | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | NSPIRE HEALTH, INC. 1830 LEFTHAND CIRCLE Longmont, CO 80501 |
| Contact | Kimberly Stark |
| Correspondent | Kimberly Stark NSPIRE HEALTH, INC. 1830 LEFTHAND CIRCLE Longmont, CO 80501 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2009-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852417003279 | K091853 | 000 |
| 00852417003262 | K091853 | 000 |
| 00852417003255 | K091853 | 000 |
| 05065016557028 | K091853 | 000 |
| 05065016557011 | K091853 | 000 |
| 05065016557004 | K091853 | 000 |