Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- NXBDispenser, Solid Medication1Product Code
- IQGAdaptor, Holder, Syringe1Product Code
- LHCWarmer, Irrigation Solution1Product Code
- K153713Getinge Series Warming Cabinet1Cleared 510(K)
- K152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes1Cleared 510(K)
- K150190IntraTemp Solution Warmer1Cleared 510(K)
- K142173NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE1Cleared 510(K)
- K142080NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED1Cleared 510(K)
- K083417INTRATEMP SOLUTION WARMER1Cleared 510(K)
- K080609SWC/DWC WARMING CABINETS1Cleared 510(K)
- K051819C CHANGE SOLUTION WARMER1Cleared 510(K)
- K0232831075LD HUSH-SLUSH1Cleared 510(K)
- K023282ORS-3000LD1Cleared 510(K)
Show All 24 Submissions
- NXQReminder, Medication1Product Code
- OIZFoot Examination Tool For Inflammatory Changes1Product Code
- OJLInsulin Vial Protector/Holder1Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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SWC/DWC WARMING CABINETS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K080609
- 510(k) Type
- Traditional
- Applicant
- MAC MEDICAL
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/13/2008
- Days to Decision
- 102 days
- Submission Type
- Summary