The following data is part of a premarket notification filed by Inhal-o-tech Medical Plastic with the FDA for Disposable Incentive Spirometer.
| Device ID | K781394 |
| 510k Number | K781394 |
| Device Name: | DISPOSABLE INCENTIVE SPIROMETER |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | INHAL-O-TECH MEDICAL PLASTIC P.O. Box 385 Blue Spring, MO 64015 |
| Contact | Joseph W Brown |
| Correspondent | Joseph W Brown INHAL-O-TECH MEDICAL PLASTIC P.O. Box 385 Blue Spring, MO 64015 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-14 |
| Decision Date | 1978-10-16 |