MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE— 510(k) K861845
Substantially EquivalentDirected Energy, Inc.
FDA 510(k) clearance K861845 for MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE, Substantially Equivalent on 1986-08-11. Applicant: Directed Energy, Inc.. Device class: 2.
Clearance details
- Applicant
- Directed Energy, Inc.
- Product code
- Code HHR
- Device class
- Class 2
- Regulation
- 21 CFR 884.4550
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
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