BZN · Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Anesthesiology · 21 CFR 868.6175 · Class 1
Overview
| Product Code | BZN |
|---|---|
| Device Name | Cart, Emergency, Cardiopulmonary (Excluding Equipment) |
| Regulation | 21 CFR 868.6175 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
| GMP Exempt | Yes |
Identification
A cardiopulmonary emergency cart is a device intended to store and transport resuscitation supplies for emergency treatment. The device does not include any equipment used in cardiopulmonary resuscitation.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K924373 | ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP | Instrumed, Inc. | Nov 25, 1992 | SESE |
| K872558 | CART, EMERGENCY, CARDIOPULMONARY | Nico Metal Products Corp. | Jul 24, 1987 | SESE |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | Medicor USA , Ltd. | Sep 19, 1985 | SESE |
| K840264 | SERVO CART 170 | Siemens Elema AB | Feb 4, 1984 | SESE |
| K832697 | RMP INTUBATION EQUIP. STORAGE TRAY | Rmp Co. | Dec 27, 1983 | SESE |
| K832356 | PORTABLE OPERAT. RM. MONITORS HS30/40 | Medtel Pty. , Ltd. | Oct 28, 1983 | SESE |
| K832355 | CRASH CART | Quinton, Inc. | Oct 28, 1983 | SESE |
| K772320 | EMERGENCY CART | Physio-Control Corp. | Jan 3, 1978 | SESE |
Top Applicants
- Instrumed, Inc. — 1 clearance
- Medicor USA , Ltd. — 1 clearance
- Medtel Pty. , Ltd. — 1 clearance
- Nico Metal Products Corp. — 1 clearance
- Physio-Control Corp. — 1 clearance
