JEH — Plethysmograph, Volume Class II
FDA product code JEH covers "Plethysmograph, Volume", a Class II medical device regulated under 21 CFR 868.1760. Submissions are reviewed by the Anesthesiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JEH
- Device Class
- Class II
- Regulation Number
- 868.1760
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240706 | ganshorn medizin electronic | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); P | December 9, 2024 |
| K223818 | vitalograph ireland | Model 9160 VitaloQUB | May 25, 2023 |
| K072061 | viasys healthcare | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | April 22, 2008 |
| K022636 | morgan scientific | BODY BOX 5500 | January 13, 2003 |
| K960840 | c.e. diagnosis | C.E. VASCULAR MACHINE | March 28, 1997 |
| K953642 | jeneric/pentron | AP-18 | December 12, 1995 |
| K951901 | erich jaeger gmbh and co. kg | MASTERSCREEN PFT BODY | July 31, 1995 |
| K936108 | erich jaeger gmbh and co. kg | MASTERSCREEN BODY | February 3, 1995 |
| K932812 | d. e. hokanson | EC 5R PLETHYSMOGRAPH | January 13, 1994 |
| K925040 | biometrix | TELEPULSE | August 23, 1993 |
| K851197 | cybermedic | CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH | July 8, 1985 |