The following data is part of a premarket notification filed by Nathaniel Gould Diagnostics, Inc. with the FDA for Computerized Orthopaedic Pedotopography Machine.
| Device ID | K881284 |
| 510k Number | K881284 |
| Device Name: | COMPUTERIZED ORTHOPAEDIC PEDOTOPOGRAPHY MACHINE |
| Classification | System, Pressure Measurement, Intermittent |
| Applicant | NATHANIEL GOULD DIAGNOSTICS, INC. 121 NORTH PLAINS INDUSTRIAL RD UNIT L Wallingford, CT 06492 |
| Contact | Greg Hutcheson |
| Correspondent | Greg Hutcheson NATHANIEL GOULD DIAGNOSTICS, INC. 121 NORTH PLAINS INDUSTRIAL RD UNIT L Wallingford, CT 06492 |
| Product Code | JFC |
| CFR Regulation Number | 890.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-25 |
| Decision Date | 1988-07-21 |