ORS-100
FDA 510(k) clearance K921568 · decided 1992-06-09
Clearance details
- K-number
- K921568
- Device name
- ORS-100
- Applicant
- Mnlase, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-04-02
- Decision date
- 1992-06-09
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JRM
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Reston, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ORS-200 (K921569) | Mnlase, Inc. | 1992-06-09 |
| ORS-300 (K921570) | Mnlase, Inc. | 1992-06-09 |
| ORS-1000 (K915427) | Mnlase, Inc. | 1992-01-07 |
| SELF-CONTAINED SURGICAL SLUSH FREEZER (K913777) | Taylor Corp. | 1991-09-25 |
| SANISERV SURGICAL SLUSH SYSTEM (K894006) | Saniserv, Inc. | 1989-11-03 |
| LANCER ICE CUBE (K782077) | Sherwood Medical Industries | 1979-04-03 |
Recalls involving this device
No recalls on record reference this clearance.