Model# 7500 Surveyor
FDA 510(k) K944611 · Devilbiss Health Care, Inc.
510(k) numberK944611
Submission
- Device name
- Model# 7500 Surveyor
- Applicant
- Devilbiss Health Care, Inc.
Somerset, PA, US - Received
- September 19, 1994
- Decision date
- April 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNR – Ventilatory Effort Recorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
Other 510(k)s with product code MNR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254042 | WatchPAT SWMNR · Traditional | Itamar Medical , Ltd. | 07/31/2026SE |
| K260050 | WRAP SystemMNR · Traditional | Huneo, LLC | 07/15/2026SE |
| K253148 | RX-1 SleepMNR · Traditional | Vivaquant, Inc. Dba Rhythm Express | 06/22/2026SE |
| K252628 | CassieMNR · Traditional | Wesper, Inc. | 04/27/2026SE |
| K252497 | Sansa HsatMNR · Traditional | Huxley Medical | 12/10/2025SE |
| K250882 | Sansa HsatMNR · Traditional | Huxley Medical | 10/29/2025SE |
| K250460 | WatchPAT400 (WP400)MNR · Traditional | Itamar Medical , Ltd. | 09/05/2025SE |
| K252383 | Somfit DMNR · Special | Compumedics Limited | 08/28/2025SE |
| K243220 | Onera STS 2 (ONERA STS 2)MNR · Traditional | Onera B.V. | 07/03/2025SE |
| K242224 | Happy Health Home Sleep TestMNR · Traditional | Happy Health, Inc. | 06/18/2025SE |
More from Happy Health, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963349 | Devilbiss 8650DBTI · Traditional | 06/13/1997SE |
| K970289 | Compressor/Nebulizer #3650CAF · Traditional | 04/15/1997SE |
| K961126 | Pulse Dose SeriesNFB · Traditional | 10/21/1996SE |
| K950849 | Model #7354BZD · Traditional | 02/08/1996SE |
| K952491 | Model 7355BZD · Traditional | 01/31/1996SE |
| K952249 | Jet NebulizerCAF · Traditional | 01/30/1996SE |
| K953815 | 5 LPM Oxygen ConcentratorCAW · Traditional | 11/09/1995SE |
| K952037 | 3 LPM Oxygen ConcentratorCAW · Traditional | 09/06/1995SE |
| K946095 | Devilbiss Model 5500CAF · Traditional | 08/24/1995SE |
| K935979 | Continuous Positive Airway Pressure CPAP SystemBZD · Traditional | 11/10/1994SE |
Questions and answers
When was Model# 7500 Surveyor cleared by the FDA?
Model# 7500 Surveyor (K944611) received a 510(k) decision of Substantially Equivalent on April 21, 1995, 214 days after the submission was received.
What is the product code of K944611?
The FDA product code is MNR – Ventilatory Effort Recorder, a Class II (moderate risk) device regulated under 21 CFR 868.2375.