The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for Iq 200 System.
| Device ID | K022774 |
| 510k Number | K022774 |
| Device Name: | IQ 200 SYSTEM |
| Classification | Counter, Urine Particle |
| Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Contact | Harvey L Kasdan |
| Correspondent | Harvey L Kasdan INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
| Product Code | LKM |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-21 |
| Decision Date | 2002-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10837461001355 | K022774 | 000 |
| 10837461001317 | K022774 | 000 |
| 10837461001300 | K022774 | 000 |
| 10837461001256 | K022774 | 000 |