The following data is part of a premarket notification filed by Iso-data, Inc. with the FDA for Iso-data 100 Series Gamma Counter.
| Device ID | K872429 |
| 510k Number | K872429 |
| Device Name: | ISO-DATA 100 SERIES GAMMA COUNTER |
| Classification | Counter (beta, Gamma) For Clinical Use |
| Applicant | ISO-DATA, INC. 1500 HICKS RD. Rolling Meadows, IL 60008 |
| Contact | John M Holub |
| Correspondent | John M Holub ISO-DATA, INC. 1500 HICKS RD. Rolling Meadows, IL 60008 |
| Product Code | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-22 |
| Decision Date | 1987-08-21 |