510(k) K013032
- Device
- PHYSIOLOG, SERIES 95000
- Applicant
- CAMTRONICS, LTD.
- 510(k) number
- K013032
- Product code
- DQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-06-04
- Date received
- 2001-09-10
- Regulation
- 870.1425
- Classification name
- Computer, Diagnostic, Programmable
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- SCOTT J PEASE
- Address
- 900 Walnut Ridge Dr. P.O. Box 950 Hartland WI US 53029 53029
FDA Registration Numbers
- 2184149
- 3005877899
- 9710602
- 1218950
- 3007603855
- 3032109181
- 3013627970
- 3001592626
- 1054713
- 3004972322
- 3010342616
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- 2134265
- 3009092139
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- 2024168
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- 2246552
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- 1018233
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- 3012552532
- 3037724692
- 3033558564
- 9681377
Source Documents
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| K253733 | STAR Apollo Mapping System | Rhythm AI, Ltd. | 2025-12-19 |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) | Edwards Lifesciences | 2025-12-18 |
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 |
| K252429 | Vektor Computational ECG Mapping System (vMap®) | Vektor Medical, Inc. | 2025-12-04 |
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Legacy Summary
summary
FDA Review
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