The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Pulsar #b Single Channel Tens-pulsar D.
Device ID | K831950 |
510k Number | K831950 |
Device Name: | PULSAR #B SINGLE CHANNEL TENS-PULSAR D |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | SPEMBLY MEDICAL LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-15 |
Decision Date | 1983-08-01 |