Heine Optotechnik GmbH & Co. KG.
GILCHING Bavaria, DE
HEINE OPTOTECHNIK GMBH & CO. KG. appears in FDA device records in GILCHING Bavaria, DE. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Heine Optotechnik GmbH & Co. KG. between 2010 and 2015. The busiest year on record is 2013, with 3. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | HLJ | Substantially Equivalent | |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | HLJ | Substantially Equivalent | |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | HLJ | Substantially Equivalent | |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | HLJ | Substantially Equivalent | |
| K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE | HLJ | Substantially Equivalent | |
| K123316 | HEINE OMEGA 500 | HLI | Substantially Equivalent | |
| K101892 | 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- | DXQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000379039 | 1000379039 | HEINE OPTOTECHNIK GMBH & CO. KG. | DORNIERSTR. 6, GILCHING Bavaria D-82205 DE | 2026 | and 12 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FERAnoscope And Accessories
- DXQBlood Pressure Cuff
- HOXChart, Visual Acuity
- FMADepressor, Tongue, Non-Surgical
- KZFDevice, Medical Examination, Ac Powered
- GCMEndoscope, Rigid
- HPPHeadlamp, Operating, Battery-Operated
- FCTHeadlight, Fiberoptic Focusing
- CCWLaryngoscope, Rigid
- HJLLens, Condensing, Diagnostic
- KYTLight, Examination, Medical, Battery Powered
- HJHLoupe, Binocular, Low Power
- HLIOphthalmoscope, Ac-Powered
- HLJOphthalmoscope, Battery-Powered
- ERAOtoscope
- HKMRetinoscope, Battery-Powered
- EPYSpeculum, Ent
- HMFStand, Instrument, Ac-Powered, Ophthalmic
- LDEStethoscope, Manual
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HJMTransilluminator, Ac-Powered
- HJNTransilluminator, Battery-Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain