Cart, Emergency, Cardiopulmonary (Excluding Equipment)
The Cart, Emergency, Cardiopulmonary (Excluding Equipment) is a mobile cart used to organize and rapidly transport emergency medical supplies and equipment to the bedside in cardiopulmonary emergency situations; the classification covers the cart itself, not the equipment stored on it. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is BZN, regulated under 21 CFR 868.6175 in the Anesthesiology specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- BZN
- Device Class
- FDA class 1
- Regulation Number
- 868.6175
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K924373 | ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP | Nov 25, 1992 | Substantially Equivalent | Instrumed, Inc. |
| K872558 | CART, EMERGENCY, CARDIOPULMONARY | Jul 24, 1987 | Substantially Equivalent | Nico Metal Products Corp. |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | Sep 19, 1985 | Substantially Equivalent | Medicor USA , Ltd. |
| K840264 | SERVO CART 170 | Feb 04, 1984 | Substantially Equivalent | Siemens Elema AB |
| K832697 | RMP INTUBATION EQUIP. STORAGE TRAY | Dec 27, 1983 | Substantially Equivalent | Rmp Co. |
| K832356 | PORTABLE OPERAT. RM. MONITORS HS30/40 | Oct 28, 1983 | Substantially Equivalent | Medtel Pty. , Ltd. |
| K832355 | CRASH CART | Oct 28, 1983 | Substantially Equivalent | Quinton, Inc. |
| K772320 | EMERGENCY CART | Jan 03, 1978 | Substantially Equivalent | Physio-Control Corp. |
FEI Numbers
This FDA classification entry is associated with 135 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 135 registration numbers. Click on an entry to view related FDA registrations.