The following data is part of a premarket notification filed by Biokinetics, Inc. with the FDA for Pedabarograph.
| Device ID | K861260 |
| 510k Number | K861260 |
| Device Name: | PEDABAROGRAPH |
| Classification | System, Pressure Measurement, Intermittent |
| Applicant | BIOKINETICS, INC. 806 FIFTEENTH STREET, N.W. SUITE 228 Washington, DC 20005 |
| Contact | Michael O Jarrett |
| Correspondent | Michael O Jarrett BIOKINETICS, INC. 806 FIFTEENTH STREET, N.W. SUITE 228 Washington, DC 20005 |
| Product Code | JFC |
| CFR Regulation Number | 890.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-03 |
| Decision Date | 1986-05-02 |