AP-18
FDA 510(k) clearance K953642 · decided 1995-12-12
Clearance details
- K-number
- K953642
- Device name
- AP-18
- Applicant
- Jeneric/Pentron, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-04
- Decision date
- 1995-12-12
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- JEH
- Device class
- 2
- Regulation number
- 868.1760
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) (K240706) | Ganshorn Medizin Electronic GmbH | 2024-12-09 |
| Model 9160 VitaloQUB (K223818) | Vitalograph Ireland, Ltd. | 2023-05-25 |
| MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY (K072061) | Viasys Healthcare GmbH | 2008-04-22 |
| BODY BOX 5500 (K022636) | Morgan Scientific, Inc. | 2003-01-13 |
| C.E. VASCULAR MACHINE (K960840) | C.E. Diagnosis, Inc. | 1997-03-28 |
| MASTERSCREEN PFT BODY (K951901) | Erich Jaeger GmbH & Co. KG | 1995-07-31 |
| MASTERSCREEN BODY (K936108) | Erich Jaeger GmbH & Co. KG | 1995-02-03 |
| EC 5R PLETHYSMOGRAPH (K932812) | D. E. Hokanson, Inc. | 1994-01-13 |
| TELEPULSE (K925040) | Biometrix , Ltd. | 1993-08-23 |
| CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH (K851197) | Cybermedic, Inc. | 1985-07-08 |
Recalls involving this device
No recalls on record reference this clearance.