The following data is part of a premarket notification filed by Q.i. Medical, Inc. with the FDA for Qtmicro(tm) System.
| Device ID | K950305 |
| 510k Number | K950305 |
| Device Name: | QTMICRO(TM) SYSTEM |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | Q.I. MEDICAL, INC. 111-B NEW MOHAWK RD. P.O. BOX 1329 Nevada City, CA 95959 |
| Contact | Hilary R Hedman |
| Correspondent | Hilary R Hedman Q.I. MEDICAL, INC. 111-B NEW MOHAWK RD. P.O. BOX 1329 Nevada City, CA 95959 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-25 |
| Decision Date | 1995-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854989006108 | K950305 | 000 |
| 00854989006078 | K950305 | 000 |