The following data is part of a premarket notification filed by Medic-aid Ltd. with the FDA for Sidestream Disposable.
| Device ID | K924123 |
| 510k Number | K924123 |
| Device Name: | SIDESTREAM DISPOSABLE |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDIC-AID LTD. 5 EAST PALLANT CHICHESTER, Sest Sussex Po19 1ts, GB |
| Contact | Morton R Pollington |
| Correspondent | Morton R Pollington MEDIC-AID LTD. 5 EAST PALLANT CHICHESTER, Sest Sussex Po19 1ts, GB |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-17 |
| Decision Date | 1992-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730004136 | K924123 | 000 |
| 00383730001500 | K924123 | 000 |
| 00383730001494 | K924123 | 000 |
| 00383730001487 | K924123 | 000 |
| 00383730001470 | K924123 | 000 |
| 00383730001463 | K924123 | 000 |
| 00383730001456 | K924123 | 000 |
| 00383730001449 | K924123 | 000 |
| 00383730001432 | K924123 | 000 |
| 00383730001517 | K924123 | 000 |
| 00383730001524 | K924123 | 000 |
| 00383730001609 | K924123 | 000 |
| 00383730001593 | K924123 | 000 |
| 00383730001586 | K924123 | 000 |
| 00383730001579 | K924123 | 000 |
| 00383730001562 | K924123 | 000 |
| 00383730001555 | K924123 | 000 |
| 00383730001548 | K924123 | 000 |
| 00383730001531 | K924123 | 000 |
| 00383730001425 | K924123 | 000 |