The following data is part of a premarket notification filed by Martell Medical Products, Inc. with the FDA for Mdm Arterial Blood Gas Kit.
| Device ID | K822786 |
| 510k Number | K822786 |
| Device Name: | MDM ARTERIAL BLOOD GAS KIT |
| Classification | Arterial Blood Sampling Kit |
| Applicant | MARTELL MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-15 |
| Decision Date | 1982-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10709078013437 | K822786 | 000 |
| 10709078013413 | K822786 | 000 |
| 10709078013390 | K822786 | 000 |
| 10709078013376 | K822786 | 000 |
| 10709078013314 | K822786 | 000 |
| 10709078013291 | K822786 | 000 |
| 10889483581995 | K822786 | 000 |