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510(k) K830058

MYOGRAPH 2000 by Prothia USA, Inc. — Product Code BXN

K830058 is an FDA 510(k) premarket notification submitted by Prothia USA, Inc. for the device "MYOGRAPH 2000". The FDA issued a decision of Substantially Equivalent on March 7, 1983. The device falls under product code BXN (Stimulator, Nerve, Battery-Powered), a Class II device regulated under 21 CFR 868.2775. Prothia USA, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1983
Date Received
January 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Battery-Powered
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

Other clearances by Prothia USA, Inc.

  • K831071 — UNIVERSAL INSTRU. SET FOR NEUROVASCULAR (June 8, 1983)
  • K830993 — AMPLIGREFFE (May 3, 1983)
  • K823581 — ELPHA 500 (March 24, 1983)
  • K823583 — MYOTEST NERVE STIMULATOR (December 30, 1982)

Other clearances for product code BXN

  • K213049 — STIMPOD NMS450 Nerve Stimulator (October 16, 2022)
  • K162086 — MultiStim ECO (January 6, 2017)
  • K153045 — SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator (May 13, 2016)
  • K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator (March 24, 2015)
  • K140853 — STIMPOD ST2-3010 NERVE STIMULATOR (November 6, 2014)
  • K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (March 28, 2013)
  • K111985 — MYOGUIDE SYSTEM MODEL 8008 (December 30, 2011)
  • K110118 — STIMTRODE SINGLE USE NERVE STIMULATOR (February 17, 2011)
  • K102084 — STIMPOD NMS450 NERVE STIMULATOR (December 16, 2010)
  • K093591 — STIMPOD MODEL NMS-400 NERVE STIMULATOR (December 3, 2009)

FDA data resources