Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
JED is the FDA product code for Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling, a class III device type, regulated under 21 CFR 868.1120. FDA's definition for this code reads: "A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- JED
- Device name
- Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
- FDA definition
- A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before May 28, 1976. Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
- Regulation
- 21 CFR 868.1120
- Device class
- Class III
- Review panel
- Anesthesiology
- Submission type
- PMA
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code JED.
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