The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Esophageal Rectal Temperature Probe.
| Device ID | K863646 |
| 510k Number | K863646 |
| Device Name: | ESOPHAGEAL RECTAL TEMPERATURE PROBE |
| 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 | 1986-09-18 |
| Decision Date | 1986-11-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10695085000457 | K863646 | 000 |
| 10695085000440 | K863646 | 000 |
| 10695085000426 | K863646 | 000 |
| 10695085000419 | K863646 | 000 |
| 10695085000402 | K863646 | 000 |