FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORS-100
K Number: K921568
·
Decision Jun 9, 1992
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
6
Applicant Total
22
Review Days
68
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Basic Information
- Device Name
- ORS-100
- K Number
- K921568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mnlase, Inc.
- Date Received
- April 2, 1992
- Decision Date
- June 9, 1992
- Product Code
- JRM
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JRM | Freezer | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRM), ordered by most recent decision date.
ORS-300
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ORS-200
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ORS-1000
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SELF-CONTAINED SURGICAL SLUSH FREEZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SANISERV SURGICAL SLUSH SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LANCER ICE CUBE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Mnlase, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944630 | MODEL 230-SAS LASER DELIVERY PROBE | Nov 9, 1994 | Substantially Equivalent |
| K944629 | MODEL 230-SAC LASER DELIVERY PROBE | Nov 3, 1994 | Substantially Equivalent |
| K944626 | MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 3, 1994 | Substantially Equivalent |
| K944471 | STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE | Nov 3, 1994 | Substantially Equivalent |
| K944627 | MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER | Nov 3, 1994 | Substantially Equivalent |
| K944470 | CURVED ENDOPHOTOCOAGULATOR LASER PROBE | Nov 3, 1994 | Substantially Equivalent |
| K944625 | MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 3, 1994 | Substantially Equivalent |
| K944628 | MODEL 220-SS LASER DELIVERY PROBE | Nov 3, 1994 | Substantially Equivalent |
| K944623 | MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 1, 1994 | Substantially Equivalent |
| K944621 | MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER | Nov 1, 1994 | Substantially Equivalent |