Bodyscreen II
FDA 510(k) K843851 · Erich Jaeger, Inc.
510(k) numberK843851
Submission
- Device name
- Bodyscreen II
- Applicant
- Erich Jaeger, Inc.
Rockford, IL, US - Received
- October 1, 1984
- Decision date
- February 14, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCM – Plethysmograph, Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1750
- Specialty
- Anesthesiology
Other 510(k)s with product code CCM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081823 | Masterscreen Paed - Baby BodyCCM · Traditional | Viasys Healthcare GmbH | 05/18/2009SE |
| K023796 | MS Paed-Baby BodyCCM · Special | Erich Jaeger GmbH | 03/03/2003SE |
| K943259 | 1085 Ultimate E PlethysmographCCM · Traditional | Medical Graphics Corp. | 04/10/1995SE |
| K893420 | Masterlab PFT and Masterlab Body BoxCCM · Traditional | Quinton, Inc. | 06/23/1989SE |
| K853390 | Infant Body TestCCM · Traditional | Erich Jaeger, Inc. | 02/05/1986SE |
| K852102 | Collin Body Plethysmograph Plus SystemCCM · Traditional | Warren E. Collins, Inc. | 07/31/1985SE |
| K852088 | System 1085 Body PlethysmographCCM · Traditional | Medical Graphics Corp. | 07/30/1985SE |
| K843846 | Universal-BodytestCCM · Traditional | Erich Jaeger, Inc. | 02/14/1985SE |
| K791705 | 4200 Pneumatic Mouth ShutterCCM · Traditional | Hans Rudolph, Inc. | 10/04/1979SE |
| K772367 | Chest Bellows, SmallCCM · Traditional | Honeywell, Inc. | 01/11/1978SE |
More from Honeywell, 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 Bodyscreen II cleared by the FDA?
Bodyscreen II (K843851) received a 510(k) decision of Substantially Equivalent on February 14, 1985, 136 days after the submission was received.
What is the product code of K843851?
The FDA product code is CCM – Plethysmograph, Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.1750.