Chrysalis Intelligence · Product Codes · FMZ

FMZ · Unclassified

5 clearances · 4 unique sponsors

Device class
Regulation —
Total clearances
5
2022-03-02 → 2026-07-28
Last 12 months
3
Unique sponsors
4
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Datex-Ohmeda, Inc. 2 2 2026-07-28
Datex Ohmeda, Inc. 1 0 2022-03-02
Mom Incubators Limited 1 0 2025-08-14
Drägerwerk AG & Co. KGaA 1 1 2026-02-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E1365 HCPCS High Neonatal incubator, double-wall
E1366 HCPCS High Neonatal incubator, single-wall
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-28 K260326 Datex-Ohmeda, Inc. Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)
2026-02-13 K251619 Drägerwerk AG & Co. KGaA Babyleo TN500
2025-10-22 K251663 Datex-Ohmeda, Inc. Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
2025-08-14 K243437 Mom Incubators Limited mOm Essential Incubator (ME1)
2022-03-02 K213553 Datex Ohmeda, Inc. Giraffe Incubator Carestation CS1