Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- FPXStrip, Adhesive, Closure, Skin1Product Code
- FPYSheet, Burn1Product Code
- KGXTape And Bandage, Adhesive1Product Code
- KMFBandage, Liquid1Product Code
- LRSI.V. Start Kit2Product Code
- K050654AMSINO I.V. START KIT2Cleared 510(K)
- K001879INFUSION IV SET2Cleared 510(K)
- K963722IV START KIT2Cleared 510(K)
- K951167EMS I.V. START KIT2Cleared 510(K)
- K950184B. BRAUN IV START KITS2Cleared 510(K)
- K944041PERSONAL HEARING SYSTEM2Cleared 510(K)
- K943941SAFESTART VASCULAR ACCESS START KIT2Cleared 510(K)
- K935684IV START KIT2Cleared 510(K)
- K942238I.V. STARTPAK VASCULAR ACCESS START KIT2Cleared 510(K)
- K941469IV START KIT2Cleared 510(K)
Show All 30 Submissions
- MCYWound Dressing Kit2Product Code
- MHWDressing, Compression1Product Code
- NECBandage, Liquid, Skin Protectant1Product Code
- OXQDressing Change Tray1Product Code
- PYOTape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use1Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PERSONAL HEARING SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K944041
- 510(k) Type
- Traditional
- Applicant
- RESOUND CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/27/1994
- Days to Decision
- 131 days
- Submission Type
- Summary