FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORS-2000 SERIES
K Number: K921633
·
Decision Jun 2, 1992
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
23
Applicant Total
22
Review Days
57
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Basic Information
- Device Name
- ORS-2000 SERIES
- K Number
- K921633
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5950
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mnlase, Inc.
- Date Received
- April 6, 1992
- Decision Date
- June 2, 1992
- Product Code
- LHC
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LHC | Warmer, Irrigation Solution | FDA class 1 | Physical Medicine |
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NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
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·Physical Medicine
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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 |