510(k) K081823
- Device
- MASTERSCREEN PAED - BABY BODY
- Applicant
- VIASYS HEALTHCARE GMBH
- 510(k) number
- K081823
- Product code
- CCM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-18
- Date received
- 2008-06-27
- Regulation
- 868.1750
- Classification name
- Plethysmograph, Pressure
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS RUST
- Address
- Leibnizstrasse 7 Hoechberg DE 97204 97204
FDA Registration Numbers#
- 9615102
- 2183022
Source Documents#
Other 510(k) Records For Product Code CCM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023796 | MS PAED-BABY BODY | Erich Jaeger GmbH | 2003-03-03 |
| K943259 | 1085 ULTIMATE E PLETHYSMOGRAPH | Medical Graphics Corp. | 1995-04-10 |
| K893420 | MASTERLAB PFT AND MASTERLAB BODY BOX | Quinton, Inc. | 1989-06-23 |
| K853390 | INFANT BODY TEST | Erich Jaeger, Inc. | 1986-02-05 |
| K852102 | COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM | Warren E. Collins, Inc. | 1985-07-31 |
| K852088 | SYSTEM 1085 BODY PLETHYSMOGRAPH | Medical Graphics Corp. | 1985-07-30 |
| K843846 | UNIVERSAL-BODYTEST | Erich Jaeger, Inc. | 1985-02-14 |
| K843851 | BODYSCREEN II | Erich Jaeger, Inc. | 1985-02-14 |
| K791705 | 4200 PNEUMATIC MOUTH SHUTTER | Hans Rudolph, Inc. | 1979-10-04 |
| K772367 | CHEST BELLOWS, SMALL | Honeywell, Inc. | 1978-01-11 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases