510(k) K023796
- Device
- MS PAED-BABY BODY
- Applicant
- ERICH JAEGER GMBH
- 510(k) number
- K023796
- Product code
- CCM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-03-03
- Date received
- 2002-11-13
- Regulation
- 868.1750
- Classification name
- Plethysmograph, Pressure
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EARL DRAPER
- Address
- 22705 Savi Ranch Pkwy. Yorba Linda CA US 92887 92887
FDA Registration Numbers#
- 2183022
- 9615102
Source Documents#
Other 510(k) Records For Product Code CCM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081823 | MASTERSCREEN PAED - BABY BODY | Viasys Healthcare GmbH | 2009-05-18 |
| 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#
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