The following data is part of a premarket notification filed by Palpometer Systems, Inc. with the FDA for Sonic Palpometer.
| Device ID | K060125 |
| 510k Number | K060125 |
| Device Name: | SONIC PALPOMETER |
| Classification | Transducer, Miniature Pressure |
| Applicant | PALPOMETER SYSTEMS, INC. R HUT MCKENZIE AVE. PO BOX 3075 STN CSC Victoria, British Columbia, CA V8w 3w2 |
| Contact | Lindsay Roach |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | IKE |
| CFR Regulation Number | 890.1615 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-01-18 |
| Decision Date | 2006-03-16 |
| Summary: | summary |