The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for No. 100352 Galvanic Oxygen Sensor.
| Device ID | K862113 |
| 510k Number | K862113 |
| Device Name: | NO. 100352 GALVANIC OXYGEN SENSOR |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | VASCULAR TECHNOLOGY INCORPORATED MEDICAL DEVICE CONSULTANTS,INC 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale VASCULAR TECHNOLOGY INCORPORATED MEDICAL DEVICE CONSULTANTS,INC 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-03 |
| Decision Date | 1986-06-19 |