Gram-Ma Neonatal SC
FDA 510(k) K853475 · Kentec Medical, Inc.
510(k) numberK853475
Submission
- Device name
- Gram-Ma Neonatal SC
- Applicant
- Kentec Medical, Inc.
Irvine, CA, US - Received
- August 20, 1985
- Decision date
- September 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRW – Scale, Patient
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.2720
- Specialty
- General Hospital
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| K954846 | Olympic Smart ScaleFRW · Traditional | Olympic Medical Corp. | 12/14/1995SE |
| K952649 | Warm-ScaleFRW · Traditional | Olympic Medical Corp. | 08/15/1995SE |
| K943587 | Advanced In-Bed Weigh SystemFRW · Traditional | Future Systems, Inc. | 09/22/1994SE |
| K932572 | Digital Baby Scale Model BLB-12FRW · Traditional | Tanita Corp. of America | 11/16/1993SE |
| K926174 | Model 9100 H.R. Infant ScaleFRW · Traditional | Acme Medical Scale Co. | 10/25/1993SE |
| K926446 | Ez PumpFRW · Traditional | Alphamed, Inc. | 09/27/1993SE |
| K926059 | 3M Model 200RT Rate Taper Infusion PumpFRW · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
| K926058 | 3M Model 280RT Rate Taper Infusion PumpFRW · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
More from 3M Health Care, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
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| K050443 | Accu-LeadDRX · Traditional | 09/02/2005SE |
| K970686 | Accutemp-ProbeFMT · Traditional | 08/25/1997SE |
| K960080 | Accutemp ProbeFMT · Traditional | 05/01/1996SE |
Questions and answers
When was Gram-Ma Neonatal SC cleared by the FDA?
Gram-Ma Neonatal SC (K853475) received a 510(k) decision of Substantially Equivalent on September 5, 1985, 16 days after the submission was received.
What is the product code of K853475?
The FDA product code is FRW – Scale, Patient, a Class I (low risk) device regulated under 21 CFR 880.2720.