Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- 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)
- K021288ORS-1000LD1Cleared 510(K)
- K021289WARMER 2000LD1Cleared 510(K)
- K002859SSW-STERILE SOLUTION WARMER1Cleared 510(K)
- K965136UROSURGE UROTHERM FLUID WARMING SYSTEM1Cleared 510(K)
- K971117WARMETTE1Cleared 510(K)
- K951300NEZHAT-DORSEY THERMAL RETENTION SYSTEM1Cleared 510(K)
- K932538CABOT MEDICAL IRRIGATION FLUID WARMER SETS1Cleared 510(K)
- K933726MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM1Cleared 510(K)
- K921633ORS-2000 SERIES1Cleared 510(K)
- K880876C-STAT/10001Cleared 510(K)
- K880252THERMAL-PAK MODEL SW 10001Cleared 510(K)
- K833944STERILE SOLUTION WARMER1Cleared 510(K)
- K832642ALPHA-I1Cleared 510(K)
- K811524AQUACADE1Cleared 510(K)
- 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
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
THERMAL-PAK MODEL SW 1000
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K880252
- 510(k) Type
- Traditional
- Applicant
- MICRO TEK ENGINEERING
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/10/1988
- Days to Decision
- 21 days