The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Esophageal/rectal Temperature Probe W/type T.
| Device ID | K864044 |
| 510k Number | K864044 |
| Device Name: | ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/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 | 1986-10-16 |
| Decision Date | 1986-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10695085000396 | K864044 | 000 |