The following data is part of a premarket notification filed by Intercure Ltd. with the FDA for Intercure Ltd. Respi-low.
| Device ID | K000405 |
| 510k Number | K000405 |
| Device Name: | INTERCURE LTD. RESPI-LOW |
| Classification | Device, Biofeedback |
| Applicant | INTERCURE LTD. 555 13TH ST. N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INTERCURE LTD. 555 13TH ST. N.W. Washington, DC 20004 -1109 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-05-17 |