The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type 9230 Temp 1 & 2 System Athena.
| Device ID | K884119 |
| 510k Number | K884119 |
| Device Name: | TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | S & W MEDICO TEKNIK 195 BROADWAY New York, NY 10007 |
| Contact | Michael Puleo |
| Correspondent | Michael Puleo S & W MEDICO TEKNIK 195 BROADWAY New York, NY 10007 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-30 |
| Decision Date | 1988-11-02 |