The following data is part of a premarket notification filed by D.r.g. Scientific Industries with the FDA for Blood Gases/ Po2, Pco2 And Blood Ph Analysis Prod..
Device ID | K863880 |
510k Number | K863880 |
Device Name: | BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. |
Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
Applicant | D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
Contact | Vincent E Corsano |
Correspondent | Vincent E Corsano D.R.G. SCIENTIFIC INDUSTRIES 1140 SARATOGA ST. East Boston, MA 02128 |
Product Code | CHL |
CFR Regulation Number | 862.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-06 |
Decision Date | 1986-11-24 |