MODEL 1220, OR E-NET (54-62 CM)— 510(k) K961609
Substantially EquivalentPhysiometrix, Inc.
FDA 510(k) clearance K961609 for MODEL 1220, OR E-NET (54-62 CM), Substantially Equivalent on 1996-05-10. Applicant: Physiometrix, Inc.. Device class: 2.
Clearance details
- Applicant
- Physiometrix, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Billerica, MA, US
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