Masterscreen Body
FDA 510(k) K936108 · Erich Jaeger GmbH & Co. KG
510(k) numberK936108
Submission
- Device name
- Masterscreen Body
- Applicant
- Erich Jaeger GmbH & Co. KG
Wuerzburg, Germany, DE - Received
- December 27, 1993
- Decision date
- February 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JEH – Plethysmograph, Volume
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1760
- Specialty
- Anesthesiology
Other 510(k)s with product code JEH
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|---|---|---|---|
| K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+)…JEH · Traditional | Ganshorn Medizin Electronic GmbH | 12/09/2024SE |
| K223818 | Model 9160 VitaloQUBJEH · Traditional | Vitalograph Ireland, Ltd. | 05/25/2023SE |
| K072061 | Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT BodyJEH · Traditional | Viasys Healthcare GmbH | 04/22/2008SE |
| K022636 | Body Box 5500JEH · Traditional | Morgan Scientific, Inc. | 01/13/2003SE |
| K960840 | C.E. Vascular MachineJEH · Traditional | C.E. Diagnosis, Inc. | 03/28/1997SE |
| K953642 | AP-18JEH · Traditional | Jeneric/Pentron, Inc. | 12/12/1995SE |
| K951901 | Masterscreen PFT BodyJEH · Traditional | Erich Jaeger GmbH & Co. KG | 07/31/1995SE |
| K932812 | Ec 5R PlethysmographJEH · Traditional | D. E. Hokanson, Inc. | 01/13/1994SE |
| K925040 | TelepulseJEH · Traditional | Biometrix , Ltd. | 08/23/1993SE |
| K851197 | Cybermedic CM-810 Body PlethysmographJEH · Traditional | Cybermedic, Inc. | 07/08/1985SE |
More from Cybermedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023120 | Oxycon MobileBZC · Traditional | 11/12/2003SE |
| K023796 | MS Paed-Baby BodyCCM · Special | 03/03/2003SE |
| K021138 | Sleepscreen/Apnoescreen CardioMNR · Traditional | 02/12/2003SE |
| K000396 | Apnoescreen Pro, Alpha Screen ProMNR · Traditional | 12/27/2000SE |
| K001502 | Aerosol Provocation System Aps Pro, Model Aps ProBZC · Special | 07/12/2000SE |
| K000648 | Spiro ProBTY · Special | 03/29/2000SE |
| K980876 | Asthma Monitor AM2BZG · Traditional | 08/14/1998SE |
| K972419 | Toennies Neuroscreen SystemIKN · Traditional | 04/30/1998SE |
| K960078 | Asthma MonitorBZG · Traditional | 09/20/1996SE |
| K954140 | Masterscreen IosBZG · Traditional | 12/14/1995SE |
Questions and answers
When was Masterscreen Body cleared by the FDA?
Masterscreen Body (K936108) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 403 days after the submission was received.
What is the product code of K936108?
The FDA product code is JEH – Plethysmograph, Volume, a Class II (moderate risk) device regulated under 21 CFR 868.1760.