Company ยท US
Healthdyne, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1995. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BZQ | Monitor, Breathing Frequency | 8 |
| CBK | Ventilator, Continuous, Facility Use | 6 |
| CAW | Generator, Oxygen, Portable | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 |
| BTI | Compressor, Air, Portable | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 |
| BZB | Catheter, Nasal, Oxygen | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 |
| BZH | Meter, Peak Flow, Spirometry | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| DQA | Oximeter | 1 |
| DSF | Recorder, Paper Chart | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 1995 | K950331 | PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) Healthdyne, Inc. | BZD |
| Jul 6, 1994 | K922106 | ALICE Healthdyne, Inc. | OLV |
| May 27, 1994 | K942357 | H-500 ALLIANCE OXYGEN CONCENTRATOR Healthdyne, Inc. | CAW |
| Apr 4, 1994 | K934502 | FLOW SPIROMETER Healthdyne, Inc. | BZH |
| Jan 7, 1993 | K924146 | OH-500 OXYGEN CONCENTRATOR Healthdyne, Inc. | CAW |
| Dec 1, 1992 | K922623 | NEBULIZER SYSTEM Healthdyne, Inc. | BTI |
| Feb 14, 1991 | K910118 | DATA RECORDER Healthdyne, Inc. | FLL |
| Aug 17, 1990 | K903287 | MODEL 900S APNEA/HEART MONITOR Healthdyne, Inc. | BZQ |
| Jan 22, 1990 | K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR Healthdyne, Inc. | HFM |
| May 23, 1989 | K892006 | HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S Healthdyne, Inc. | DRT |
| Jan 31, 1989 | K890150 | H-3000 OXYGEN CONCENTRATOR Healthdyne, Inc. | CAW |
| Jun 24, 1988 | K881833 | NASAL CPAP SYSTEM Healthdyne, Inc. | BYE |
| Feb 12, 1988 | K875031 | OXYGEN/PULSE MONITOR Healthdyne, Inc. | DQA |
| Feb 11, 1988 | K874814 | HEALTHDYNE RATE METER Healthdyne, Inc. | BZQ |
| Jan 29, 1988 | K874695 | HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 Healthdyne, Inc. | DRT |
| May 21, 1986 | K861484 | INFANT MONITOR Healthdyne, Inc. | BZQ |
| Jan 30, 1986 | K860254 | HEALTHDYNE'S EVENT RECORDER SYSTEM Healthdyne, Inc. | BZQ |
| Jan 3, 1986 | K854374 | OXYGEN CONCENTRATOR, MODEL BX-5000 Healthdyne, Inc. | CAW |
| Aug 15, 1985 | K853300 | HEALTHDYNE IMPLUSE VENTILATOR Healthdyne, Inc. | CBK |
| Oct 10, 1984 | K843546 | INFANT MONITOR 16900 Healthdyne, Inc. | BZQ |
| Jun 26, 1984 | K842207 | WAKO B.G. PRETEST STRIPS Healthdyne, Inc. | CGA |
| Jun 5, 1984 | K841818 | IMPULSE VENTILATOR Healthdyne, Inc. | CBK |
| Mar 19, 1984 | K833351 | DEMAND OXYGEN CONTROLLER Healthdyne, Inc. | BZB |
| Feb 23, 1984 | K840345 | IMPULSE VENTILATOR Healthdyne, Inc. | CBK |
| Feb 3, 1984 | K834099 | BLOOD GLUCOSE MONITOR Healthdyne, Inc. | JJQ |
| Oct 22, 1982 | K822871 | MODEL BX-3000 OXYGEN CONCENTRATOR Healthdyne, Inc. | CAW |
| Jul 14, 1982 | K821612 | MODEL 16800 TREND RECORDER Healthdyne, Inc. | DSF |
| Jul 13, 1982 | K821731 | HEALTHDYNE MODEL 16900 INFANT MONITOR Healthdyne, Inc. | BZQ |
| Apr 15, 1982 | K820645 | INFANT MONITOR Healthdyne, Inc. | BZQ |
| Feb 4, 1982 | K813254 | JET VENTILATOR Healthdyne, Inc. | CBK |
| Feb 12, 1981 | K810255 | MEAN PRESSURE MONITOR Healthdyne, Inc. | CAP |
| Dec 18, 1980 | K802583 | INFANT VENTILATOR, (RESPIRATOR) PLAN B Healthdyne, Inc. | CBK |
| Oct 3, 1980 | K802205 | ECG/RESPIRATION STIMULATOR Healthdyne, Inc. | BZQ |
| Dec 21, 1978 | K781926 | VENTILATOR, INFANT MODEL 100 Healthdyne, Inc. | CBK |
| Nov 14, 1978 | K781530 | TEMPERATURE CONTROLLER MODEL 17000 Healthdyne, Inc. | BZE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||