The following data is part of a premarket notification filed by Essential Medical Supply, Inc. with the FDA for Endurance R3000.
| Device ID | K942384 |
| 510k Number | K942384 |
| Device Name: | ENDURANCE R3000 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ESSENTIAL MEDICAL SUPPLY, INC. 6937-A STAPOINT COURT Winter Park, FL 32792 |
| Contact | Carol A Hoepner |
| Correspondent | Carol A Hoepner ESSENTIAL MEDICAL SUPPLY, INC. 6937-A STAPOINT COURT Winter Park, FL 32792 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1994-12-19 |