The following data is part of a premarket notification filed by Hf Scientific, Inc. with the FDA for Ref. Membrane For Orion 1020 Sodium/potassium Ana..
| Device ID | K864862 |
| 510k Number | K864862 |
| Device Name: | REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA. |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
| Contact | Barbara H Sneade |
| Correspondent | Barbara H Sneade HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-11 |
| Decision Date | 1987-02-20 |