NEUROMEDICS ORIONS #660-01— 510(k) K822600
Substantially EquivalentIntermedics, Inc.
FDA 510(k) clearance K822600 for NEUROMEDICS ORIONS #660-01, Substantially Equivalent on 1982-09-24. Applicant: Intermedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Intermedics, Inc.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GZJ
view allMore clearances from Intermedics, Inc.
view all- K954610 — MODEL 430-07 ENDOCARDIAL PACING LEAD
- K955122 — INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
- K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
- K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
- K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY
Data sourced from openFDA. This site is unofficial and independent of the FDA.