MODUFLEX NEONATAL VENTILATOR SET
FDA 510(k) clearance K823479 · decided 1982-12-15
Clearance details
- K-number
- K823479
- Device name
- MODUFLEX NEONATAL VENTILATOR SET
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1982-11-23
- Decision date
- 1982-12-15
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- BZO
- Device class
- 1
- Regulation number
- 868.5975
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Washington, DC, 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 |
|---|---|---|
| UNICOR, INC. CORRUGATED TUBING (K953784) | Unicor, Inc. | 1995-09-19 |
| UNICOR, INC. VENTILATOR HOSES (K953785) | Unicor, Inc. | 1995-09-18 |
| PRIMA VENTILATOR HOSES (K952010) | Prima, Inc. | 1995-05-22 |
| PRIMA VOLUMN VENTILATORSS (K952022) | Prima, Inc. | 1995-05-22 |
| PRIMA CUSTOM ANESTESIA CIRCUIT (K952012) | Prima, Inc. | 1995-05-22 |
| PRIMA BREATHING BAGS (K952011) | Prima, Inc. | 1995-05-22 |
| INFANT FLOW SYSTEM (K945740) | Hamilton Medical, Inc. | 1995-03-23 |
| PRIMA, INC. CORRUGATED TUBING (K944531) | Prima, Inc. | 1994-12-02 |
| VENTILATOR HOSE (K942569) | Med-Plastics Intl., Inc. | 1994-06-10 |
| VOLUME VENTILATOR (K942572) | Med-Plastics Intl., Inc. | 1994-06-10 |
| TUBE, INHALER OXYGEN (K935582) | Puritas Health Care, Inc. | 1994-01-14 |
| STAR BREATHING CIRCUITS (K934753) | Infrasonics Corp. | 1993-10-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |