The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Cold Cd Asp Module, Ite.
| Device ID | K933041 |
| 510k Number | K933041 |
| Device Name: | COLD CD ASP MODULE, ITE |
| Classification | I.v. Start Kit |
| Applicant | ELECTONE, INC. 1124 FLORIDA CENTRAL PKWY. Longwood, FL 32750 |
| Contact | Jim Nee |
| Correspondent | Jim Nee ELECTONE, INC. 1124 FLORIDA CENTRAL PKWY. Longwood, FL 32750 |
| Product Code | LRS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-28 |
| Decision Date | 1993-08-02 |