The following data is part of a premarket notification filed by Ackrad Laboratories with the FDA for Ackrad Tdi Set.
| Device ID | K864818 |
| 510k Number | K864818 |
| Device Name: | ACKRAD TDI SET |
| Classification | Probe, Thermodilution |
| Applicant | ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Contact | Bernard Ackerman |
| Correspondent | Bernard Ackerman ACKRAD LABORATORIES 70 JACKSON DR. Cranford, NJ 07016 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-04-09 |