The following data is part of a premarket notification filed by Myron L Company with the FDA for Dialysate Meter, Model D-6.
| Device ID | K100237 |
| 510k Number | K100237 |
| Device Name: | DIALYSATE METER, MODEL D-6 |
| Classification | Meter, Conductivity, Induction, Remote Type |
| Applicant | MYRON L COMPANY 2450 IMPALA DR. Carlsbad, CA 92010 -7226 |
| Contact | Richard James Spahl |
| Correspondent | Richard James Spahl MYRON L COMPANY 2450 IMPALA DR. Carlsbad, CA 92010 -7226 |
| Product Code | FLB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-26 |
| Decision Date | 2010-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857744006054 | K100237 | 000 |
| 00857744006047 | K100237 | 000 |
| 00857744006030 | K100237 | 000 |
| 00857744006023 | K100237 | 000 |