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
- Subpart F—Therapeutic DevicesCFR Sub-Part
- CAHFilter, Bacterial, Breathing-Circuit2Product Code
- MAJCatheter, Percutaneous, Intraspinal, Short Term2Product Code
- OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)1Product Code
- LEYSet, Oral Administration2Product Code
- NIHDisinfectant, Subsystem, Water Purification2Product Code
- NIIDisinfectant, Dialysate Delivery System2Product Code
- FLJUnit, Airflow, Laminar2Product Code
- FRTUnit, Isolation, Surgical2Product Code
- FYDApparatus, Exhaust, Surgical2Product Code
- ORCAir Filter Portable Apparatus2Product Code
- QGIAir-Handling Apparatus Accessory1Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Air-Handling Apparatus Accessory
- Page Type
- Product Code
- Definition
- An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches.
- Physical State
- The accessory are made from metal or hard plastic that are either located within the parent device or on the peripheral of the parent device.
- Technical Method
- The accessory devices provide an interface between the components of the parent device. These devices are much less complex in nature than the parent device or other components which provide the surgical exhaust mechanism or conduit.
- Target Area
- NA
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- General Hospital
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 878.5080
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 878.5080 Air-handling apparatus accessory
§ 878.5080 Air-handling apparatus accessory.
(a) Identification. An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
[84 FR 14870, Apr. 12, 2019]