The following data is part of a premarket notification filed by Warren E. Collins, Inc. with the FDA for The Spira Elektro 2.
| Device ID | K871151 |
| 510k Number | K871151 |
| Device Name: | THE SPIRA ELEKTRO 2 |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | WARREN E. COLLINS, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Contact | James Tully |
| Correspondent | James Tully WARREN E. COLLINS, INC. 220 WOOD RD. Braintree, MA 02184 -2408 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-23 |
| Decision Date | 1987-05-15 |