The following data is part of a premarket notification filed by Fisher & Paykel Electronics Ltd. with the FDA for Cons. Current Periph. Nerve Loc. Ns232,ns262,ns272.
Device ID | K924234 |
510k Number | K924234 |
Device Name: | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 |
Classification | Stimulator, Nerve, Peripheral, Electric |
Applicant | FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
Contact | Richard Belgrave |
Correspondent | Richard Belgrave FISHER & PAYKEL ELECTRONICS LTD. 25 CARBINE ROAD PANMURE P.O. BOX 14 348 PANMURE Auckland, New Zealand, NZ |
Product Code | KOI |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-24 |
Decision Date | 1993-05-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
09420012408174 | K924234 | 000 |