510(k) K022636
- Device
- BODY BOX 5500
- Applicant
- MORGAN SCIENTIFIC, INC.
- 510(k) number
- K022636
- Product code
- JEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-13
- Date received
- 2002-08-08
- Regulation
- 868.1760
- Classification name
- Plethysmograph, Volume
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK F MORGAN
- Address
- 151 Essex St. Haverhill MA US 01832 01832
FDA Registration Numbers#
- 1314417
- 3003630525
- 3006419626
- 8030673
- 3033959233
- 9615102
- 3002808458
- 3008505660
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JEH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | Ganshorn Medizin Electronic GmbH | 2024-12-09 |
| K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | 2023-05-25 |
| K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | Viasys Healthcare GmbH | 2008-04-22 |
| K960840 | C.E. VASCULAR MACHINE | C.E. Diagnosis, Inc. | 1997-03-28 |
| K953642 | AP-18 | Jeneric/Pentron, Inc. | 1995-12-12 |
| K951901 | MASTERSCREEN PFT BODY | Erich Jaeger GmbH & Co. KG | 1995-07-31 |
| K936108 | MASTERSCREEN BODY | Erich Jaeger GmbH & Co. KG | 1995-02-03 |
| K932812 | EC 5R PLETHYSMOGRAPH | D. E. Hokanson, Inc. | 1994-01-13 |
| K925040 | TELEPULSE | Biometrix , Ltd. | 1993-08-23 |
| K851197 | CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH | Cybermedic, Inc. | 1985-07-08 |
Legacy Summary#
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FDA Review#
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