FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WARMER 2000LD
K Number: K021289
·
Decision Jun 26, 2002
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
23
Applicant Total
7
Review Days
64
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Basic Information
- Device Name
- WARMER 2000LD
- K Number
- K021289
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5950
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- O.R. Solutions, Inc.
- Date Received
- April 23, 2002
- Decision Date
- June 26, 2002
- 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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Other Clearances by O.R. Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051979 | ORS MODEL 6000 ENDOSCOPE HOLDER | Aug 30, 2005 | Substantially Equivalent |
| K023282 | ORS-3000LD | Nov 13, 2002 | Substantially Equivalent |
| K023283 | 1075LD HUSH-SLUSH | Nov 13, 2002 | Substantially Equivalent |
| K021288 | ORS-1000LD | Jun 27, 2002 | Substantially Equivalent |
| K960836 | DMS-9000 | Sep 12, 1996 | Substantially Equivalent |
| K953654 | ORS-111 | Sep 22, 1995 | Substantially Equivalent |