The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Spirometer, Incentive Catalog # 1750.
| Device ID | K781831 |
| 510k Number | K781831 |
| Device Name: | SPIROMETER, INCENTIVE CATALOG # 1750 |
| Classification | Spirometer, Therapeutic (incentive) |
| Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BWF |
| CFR Regulation Number | 868.5690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-30 |
| Decision Date | 1978-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704630111 | K781831 | 000 |
| 24026704595536 | K781831 | 000 |
| 24026704390513 | K781831 | 000 |