GAMMA CAMERA— 510(k) K780969
Substantially EquivalentMachlett Laboratories, Inc.
FDA 510(k) clearance K780969 for GAMMA CAMERA, Substantially Equivalent on 1978-06-27. Applicant: Machlett Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Machlett Laboratories, Inc.
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code IYX
view allMore clearances from Machlett Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.