The following data is part of a premarket notification filed by Spectrum Medical Ltd with the FDA for Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas.
| Device ID | K173591 |
| 510k Number | K173591 |
| Device Name: | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GB Gl2 9ql |
| Contact | Mark Drain |
| Correspondent | Mark Drain Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East Gloucester, GB Gl2 9ql |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-21 |
| Decision Date | 2018-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060434420893 | K173591 | 000 |
| 05060434422354 | K173591 | 000 |
| 05060434423283 | K173591 | 000 |
| 05060434423290 | K173591 | 000 |
| 05060434423306 | K173591 | 000 |
| 05060434420695 | K173591 | 000 |
| 05060434420701 | K173591 | 000 |
| 05060434420817 | K173591 | 000 |
| 05060434420886 | K173591 | 000 |
| 05060434422231 | K173591 | 000 |