The following data is part of a premarket notification filed by Penny & Giles Blackwood Ltd. with the FDA for Goniometer And Biomedical Recorder System.
| Device ID | K884003 |
| 510k Number | K884003 |
| Device Name: | GONIOMETER AND BIOMEDICAL RECORDER SYSTEM |
| Classification | Goniometer, Ac-powered |
| Applicant | PENNY & GILES BLACKWOOD LTD. BLACKWOOD GWENT NP2 SYD, UNITED KINGDOM England, GB |
| Contact | Dr. I Thomas |
| Correspondent | Dr. I Thomas PENNY & GILES BLACKWOOD LTD. BLACKWOOD GWENT NP2 SYD, UNITED KINGDOM England, GB |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-21 |
| Decision Date | 1988-12-19 |