RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
FDA 510(k) clearance K950914 · decided 1995-07-24
Clearance details
- K-number
- K950914
- Device name
- RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
- Applicant
- Rudolf Riester GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 1995-02-23
- Decision date
- 1995-07-24
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- HLJ
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- D-72417 Jungingen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rudolf Riester GmbH & Co. KG
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.