Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- DYJRetainer, Screw Expansion, Orthodontic1Product Code
- DYOBand, Material, Orthodontic1Product Code
- DYTMaintainer, Space Preformed, Orthodontic1Product Code
- DYWBracket, Plastic, Orthodontic2Product Code
- DZBHeadgear, Extraoral, Orthodontic2Product Code
- DZCWire, Orthodontic1Product Code
- DZDTube, Orthodontic1Product Code
- ECIBand, Elastic, Orthodontic1Product Code
- ECMBand, Preformed, Orthodontic1Product Code
- ECNClamp, Wire, Orthodontic1Product Code
- ECOSpring, Orthodontic1Product Code
- EJFBracket, Metal, Orthodontic1Product Code
- KKORing, Teething, Fluid-Filled2Product Code
- KMYPositioner, Tooth, Preformed1Product Code
- LQZDevice, Jaw Repositioning2Product Code
- K233754AIO Breathe2Cleared 510(K)
- K230532RADx Intraoral Appliance for Snoring and Sleep Apnea2Cleared 510(K)
- K203712The Slide2Cleared 510(K)
- K191320Slow Wave DS82Cleared 510(K)
- K192581The NightBlocks Appliance2Cleared 510(K)
- K162816SML-OSA2 Appliances2Cleared 510(K)
- K130130ATG/SM-OSA APPLIANCES2Cleared 510(K)
- K112627MILLENIUM ANTI-SNORING DEVICE2Cleared 510(K)
- K112766SNORKEL2Cleared 510(K)
- K113201NARVAL CC2Cleared 510(K)
- K090911IST SNORING APPLIANCE2Cleared 510(K)
- K091035FULL BREATH SLEEP APPLIANCE LOWER (FBSL)2Cleared 510(K)
- K061228FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR2Cleared 510(K)
- K053065FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)2Cleared 510(K)
- K052862FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)2Cleared 510(K)
- K032410SNORENTI2Cleared 510(K)
- K971818SNOREX2Cleared 510(K)
- K960673OSAP2Cleared 510(K)
- K955503ADJUSTABLE PM POSITIONER2Cleared 510(K)
- K953293PM POSITIONER2Cleared 510(K)
- K945820DESRA2Cleared 510(K)
- K946112ELASTOMERIC SLEEP APPLIANCE2Cleared 510(K)
- K932932SNOREMASTER SNORE REMEDY2Cleared 510(K)
- K922818SNORE-NO-MORE2Cleared 510(K)
- K902790NAPA2Cleared 510(K)
- K880956SNOAR(TM) OPEN AIRWAY APPLIANCE2Cleared 510(K)
- K870501THE EQUALIZER AIRWAY DEVICE2Cleared 510(K)
- LRKDevice, Anti-Snoring2Product Code
- LTFStimulator, Salivary System2Product Code
- MEFRing, Teething, Non-Fluid Filled1Product Code
- NJMBracket, Ceramic, Orthodontic2Product Code
- NLCBracket, Plastic, Orthodontic, Reprocessed2Product Code
- NQSBracket, Metal, Orthodontic, Reprocessed1Product Code
- NTORinse, Oral, Antibacterial (By Physical Means)2Product Code
- NXCAligner, Sequential2Product Code
- PLCSleep Appliances With Patient Monitoring2Product Code
- OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea2Product Code
- ORYPrelude Tongue Suspension System2Product Code
- OYHOrthodontic Vibratory Accessory2Product Code
- PLHOrthodontic Led Accessory2Product Code
- PNNOrthodontic Software2Product Code
- QCJClosed Loop Auto Titration Device For Oral Appliances2Product Code
- QJJIndirect Bonding Tray1Product Code
- QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea2Product Code
- QTTOver The Counter Electrical Salivary Stimulatory System2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- 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
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- UnknownReview Panel
DESRA
- Page Type
- Cleared 510(K)
- 510(k) Number
- K945820
- 510(k) Type
- Traditional
- Applicant
- D.S.R.A., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/15/1995
- Days to Decision
- 199 days
- Submission Type
- Statement