510(k) K924373
- Device
- ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP
- Applicant
- INSTRUMED, INC.
- 510(k) number
- K924373
- Product code
- BZN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-11-25
- Date received
- 1992-08-28
- Regulation
- 868.6175
- Classification name
- Cart, Emergency, Cardiopulmonary (excluding Equipment)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JERRY L SPENCE
- Address
- 11818 N. Creek Pkwy. N. Suite 105 Bothell WA US 98011 98011
FDA Registration Numbers#
- 2953200
- 3004499949
- 3023443842
- 3028006458
- 3030516433
- 3017421556
- 3012644426
- 3010030809
- 3010373263
- 3014615697
- 3017944270
- 2225311
- 3005083075
- 3014270896
- 3012536737
- 3033589330
- 3010399422
- 3013182765
- 3011092264
- 3004111085
- 3010373530
- 3004636440
- 3030522263
- 9613910
- 3008281139
- 3003574554
- 3006553621
- 3015465361
- 3042991836
- 3016851379
- 3014193078
- 1833497
- 3005214422
- 3011122894
- 3010774780
- 3012316249
- 9681599
- 3013875599
- 3004068465
- 1450997
- 9680741
- 3027847726
- 9615439
- 9680168
- 3010097171
- 3037012186
- 3015309643
- 3033433849
- 3029871637
- 3001109397
- 3003135857
- 3014256877
- 3011719874
- 3038191348
- 3006697299
- 1526439
- 2518897
- 3006799874
- 3031582440
- 3023189540
- 3015060224
- 3006446479
- 2027062
- 3002821232
- 3010331645
- 3003418325
- 1937397
- 3014739961
- 3007518294
- 3010394125
- 3007499787
- 3011537487
- 3005706637
- 3007019343
- 3002579136
- 2085249
- 3011580044
- 3010834934
- 3021599329
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BZN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872558 | CART, EMERGENCY, CARDIOPULMONARY | Nico Metal Products Corp. | 1987-07-24 |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | Medicor USA , Ltd. | 1985-09-19 |
| K840264 | SERVO CART 170 | Siemens Elema AB | 1984-02-04 |
| K832697 | RMP INTUBATION EQUIP. STORAGE TRAY | Rmp Co. | 1983-12-27 |
| K832355 | CRASH CART | Quinton, Inc. | 1983-10-28 |
| K832356 | PORTABLE OPERAT. RM. MONITORS HS30/40 | Medtel Pty. , Ltd. | 1983-10-28 |
| K772320 | EMERGENCY CART | Physio-Control Corp. | 1978-01-03 |
Legacy Summary#
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FDA Review#
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