MODEL 9310 LUNG WATER COMPUTER
FDA premarket approval P800003/S001 · decided 1981-06-12
Approval details
- PMA number
- P800003
- Supplement
- S001
- Trade name
- MODEL 9310 LUNG WATER COMPUTER
- Generic name
- MONITOR, LUNG WATER MEASUREMENT
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 1981-03-17
- Decision date
- 1981-06-12
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- JEZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Irvine, CA
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
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| Edwards MC3 Tricuspid annuloplasty ring (4900) (K251982) | Edwards Lifesciences, LLC | 2025-09-23 |
| Carpentier-Edwards Physio Annuloplasty Ring (4450) (K251688) | Edwards Lifesciences, LLC | 2025-09-17 |
| Hypertension Prediction Index (HePI) Algorithm (K242518) | Edwards Lifesciences, LLC | 2025-05-15 |
| FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors (K242909) | Edwards Lifesciences, LLC | 2025-03-21 |
| Fogarty Thru-Lumen Embolectomy Catheter (K240078) | Edwards Lifesciences, LLC | 2024-08-28 |
| Acumen Assisted Fluid Management (AFM) Software Feature (K233984) | Edwards Lifesciences, LLC | 2024-08-02 |