The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Vascular Tech # 100123 Polarographic Oxgyen Sensor.
Device ID | K852275 |
510k Number | K852275 |
Device Name: | VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | VASCULAR TECHNOLOGY INCORPORATED MEDICAL DEVICE CONSULTANTS,INC 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
Contact | William A Morton |
Correspondent | William A Morton 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 | 1985-05-29 |
Decision Date | 1985-06-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817122020072 | K852275 | 000 |
00817122020027 | K852275 | 000 |
00817122020003 | K852275 | 000 |