Portable Operat. Rm. Monitors HS30/40
FDA 510(k) K832356 · Medtel Pty. , Ltd.
510(k) numberK832356
Submission
- Device name
- Portable Operat. Rm. Monitors HS30/40
- Applicant
- Medtel Pty. , Ltd.
Mchenry, IL, US - Received
- July 18, 1983
- Decision date
- October 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZN – Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.6175
- Specialty
- Anesthesiology
Other 510(k)s with product code BZN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924373 | Accuflate Accessorie Cart W/Iv Pole and ClampBZN · Traditional | Instrumed, Inc. | 11/25/1992SE |
| K872558 | Cart, Emergency, CardiopulmonaryBZN · Traditional | Nico Metal Products Corp. | 07/24/1987SE |
| K850761 | Model Pcx/Emy 525A Microprocesssor Control X-Ray CBZN · Traditional | Medicor USA , Ltd. | 09/19/1985SE |
| K840264 | Servo Cart 170BZN · Traditional | Siemens Elema AB | 02/04/1984SE |
| K832697 | RMP Intubation Equip. Storage TrayBZN · Traditional | Rmp Co. | 12/27/1983SE |
| K832355 | Crash CartBZN · Traditional | Quinton, Inc. | 10/28/1983SE |
| K772320 | Emergency CartBZN · Traditional | Physio-Control Corp. | 01/03/1978SE |
More from Physio-Control Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K820670 | HS17/HS18 Series MonitorsFLL · Traditional | 04/09/1982SE |
| K820671 | CM10 Central Monitoring SystemDRT · Traditional | 04/01/1982SE |
| K820399 | HS20 Port. Operating Room MonitorDRT · Traditional | 03/22/1982SE |
| K802184 | HS10 Portable Operating Room MonitorDRT · Traditional | 09/26/1980SE |
| K800243 | D668 & D664 Central Monitoring SystemsDRT · Traditional | 04/10/1980SE |
| K791839 | H59 Critical Care MonitorDSK · Traditional | 10/01/1979SE |
| K791838 | HSH/H512 Adult Physiological MonitorsDSK · Traditional | 10/01/1979SE |
Questions and answers
When was Portable Operat. Rm. Monitors HS30/40 cleared by the FDA?
Portable Operat. Rm. Monitors HS30/40 (K832356) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 102 days after the submission was received.
What is the product code of K832356?
The FDA product code is BZN – Cart, Emergency, Cardiopulmonary (Excluding Equipment), a Class I (low risk) device regulated under 21 CFR 868.6175.