HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-— 510(k) K101892
Substantially EquivalentHeine Optotechnik GmbH & Co. KG
FDA 510(k) clearance K101892 for HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M-, Substantially Equivalent on 2010-08-27. Applicant: Heine Optotechnik GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Heine Optotechnik GmbH & Co. KG
- Product code
- Code DXQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1120
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamburg, DE
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More clearances from Heine Optotechnik GmbH & Co. KG
view allData sourced from openFDA. This site is unofficial and independent of the FDA.