Healthdyne, Inc.
Healthdyne, Inc. appears in FDA public data with 0 recalls, 35 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 21, 1995.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 35
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) | September 21, 1995 |
| K922106 | ALICE | July 6, 1994 |
| K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR | May 27, 1994 |
| K934502 | FLOW SPIROMETER | April 4, 1994 |
| K924146 | OH-500 OXYGEN CONCENTRATOR | January 7, 1993 |
| K922623 | NEBULIZER SYSTEM | December 1, 1992 |
| K910118 | DATA RECORDER | February 14, 1991 |
| K903287 | MODEL 900S APNEA/HEART MONITOR | August 17, 1990 |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | January 22, 1990 |
| K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S | May 23, 1989 |
| K890150 | H-3000 OXYGEN CONCENTRATOR | January 31, 1989 |
| K881833 | NASAL CPAP SYSTEM | June 24, 1988 |
| K875031 | OXYGEN/PULSE MONITOR | February 12, 1988 |
| K874814 | HEALTHDYNE RATE METER | February 11, 1988 |
| K874695 | HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 | January 29, 1988 |
| K861484 | INFANT MONITOR | May 21, 1986 |
| K860254 | HEALTHDYNE'S EVENT RECORDER SYSTEM | January 30, 1986 |
| K854374 | OXYGEN CONCENTRATOR, MODEL BX-5000 | January 3, 1986 |
| K853300 | HEALTHDYNE IMPLUSE VENTILATOR | August 15, 1985 |
| K843546 | INFANT MONITOR 16900 | October 10, 1984 |