The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Surface Skin Temp Probe W/thermocouple Type T.
| Device ID | K864195 |
| 510k Number | K864195 |
| Device Name: | SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE T |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Contact | Anthony V Beran |
| Correspondent | Anthony V Beran RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-27 |
| Decision Date | 1986-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10695085000211 | K864195 | 000 |
| 20695085000102 | K864195 | 000 |
| 10695085000112 | K864195 | 000 |
| 10695085000129 | K864195 | 000 |
| 20695085000133 | K864195 | 000 |
| 10695085000143 | K864195 | 000 |
| 20695085000157 | K864195 | 000 |
| 20695085000164 | K864195 | 000 |
| 10695085000174 | K864195 | 000 |
| 10695085000181 | K864195 | 000 |
| 20695085000195 | K864195 | 000 |
| 20695085000201 | K864195 | 000 |
| 30610674804906 | K864195 | 000 |