The following data is part of a premarket notification filed by Qrs Diagnostic, Llc. with the FDA for Spiroxcard Diagnostic Spirometer And Pulse Oximeter.
| Device ID | K001995 |
| 510k Number | K001995 |
| Device Name: | SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH Plymouth, MN 55447 |
| Contact | Jill R Krall |
| Correspondent | Jill R Krall QRS DIAGNOSTIC, LLC. 14755 27TH AVE.NORTH Plymouth, MN 55447 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-30 |
| Decision Date | 2000-09-08 |