The following data is part of a premarket notification filed by Equilibrated Bio Systems, Inc. with the FDA for Turboaire Challanger Environmental Air Controller.
| Device ID | K843996 |
| 510k Number | K843996 |
| Device Name: | TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER |
| Classification | Spirometer, Diagnostic |
| Applicant | EQUILIBRATED BIO SYSTEMS, INC. 900 WALT WHITMAN RD. Melville, NY 11747 |
| Contact | Alex Stenzler |
| Correspondent | Alex Stenzler EQUILIBRATED BIO SYSTEMS, INC. 900 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1984-11-20 |