Product code JEH— Anesthesiology
AP-18
- Classification name
- Plethysmograph, Volume
- Device class
- Class 2
- Regulation
- 21 CFR 868.1760
- Advisory panel
- Anesthesiology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code JEH
FDA has cleared devices under product code JEH between 1985 and 2024, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2024
- 2023
- 2008
- 2003
- 1997
- 1995
- 1994
- 1993
- 1985
Top applicants under product code JEH
Recent clearances under product code JEH
- K240706 — PowerCube+ Series (3 models)
- K223818 — Model 9160 VitaloQUB
- K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
- K022636 — BODY BOX 5500
- K960840 — C.E. VASCULAR MACHINE
- K953642 — AP-18
- K951901 — MASTERSCREEN PFT BODY
- K936108 — MASTERSCREEN BODY
- K932812 — EC 5R PLETHYSMOGRAPH
- K925040 — TELEPULSE
- K851197 — CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH
Data sourced from openFDA. This site is unofficial and independent of the FDA.